Regulatory Event

FDA Approval

FDA approval decisions, complete response letters, and label expansions across new and supplemental applications.

Recent events: 456
Catalysts: 2
Companies: 95

Recent events(456)

RegulatoryAugust 19, 2026

FDA Approval Status for Buprenorphine and Naloxone Hydrochloride by Difgen Pharms

The FDA has granted an approval status (AP) for ANDA212756, a supplemental application for Buprenorphine Hydrochloride and Naloxone Hydrochloride submitted by Difgen Pharms.

RegulatoryAugust 19, 2026

FDA Approval Application for TAUKLARIFY by Cervaeu Technologies

Cervaeu Technologies has submitted an NDA for TAUKLARIFY (FLORQUINITAU F18) with a standard review priority, indicating that the FDA will evaluate the application under typical timelines.

RegulatoryAugust 19, 2026

ANDA201991 for Metformin Hydrochloride Approved by FDA

The FDA has approved the ANDA201991 application for Metformin Hydrochloride submitted by Inventia, classified under standard review priority.

RegulatoryAugust 19, 2026

FDA Approves Supplement for Janumet (Metformin/Sitagliptin) by Merck

The FDA has approved a supplemental application for Janumet, a combination of Metformin Hydrochloride and Sitagliptin Phosphate, submitted by Merck.

RegulatoryAugust 19, 2026

FDA Approval Status for Metformin Hydrochloride ANDA076033 by Senores Pharms

The FDA has assigned an Approval Pending (AP) status to ANDA076033 for Metformin Hydrochloride submitted by Senores Pharms.

RegulatoryAugust 18, 2026

FDA Approval Update for KOMBIGLYZE XR Supplement by AstraZeneca

The FDA has accepted the supplemental application NDA200678 for KOMBIGLYZE XR, a combination of metformin hydrochloride and saxagliptin hydrochloride, submitted by AstraZeneca.

RegulatoryAugust 18, 2026

FDA Approval Status for Metformin Hydrochloride ANDA075965 by Epic Pharma

Epic Pharma LLC has received an Abbreviated New Drug Application (ANDA) approval status for Metformin Hydrochloride under application number ANDA075965.

RegulatoryAugust 18, 2026

FDA Approves Supplement for Metformin Hydrochloride by Sun Pharma

The FDA has approved a supplemental application (ANDA075967) for Metformin Hydrochloride submitted by Sun Pharmaceutical Industries. This approval confirms the safety and efficacy of Sun Pharma's formulation, allowing it to compete more effectively in the diabetes market.

RegulatoryAugust 18, 2026

FDA Approval for Clindamycin Phosphate and Benzoyl Peroxide by Actavis Labs

The FDA has approved ANDA208757 for Clindamycin Phosphate and Benzoyl Peroxide, submitted by Actavis Labs.

RegulatoryAugust 18, 2026

FDA Approval Status Update for Deflazacort ANDA216992 by Upsher Smith Labs

The FDA has granted an approval status of 'AP' for the ANDA216992 application for Deflazacort submitted by Upsher Smith Labs.

RegulatoryAugust 18, 2026

FDA Approval Status Update for MESNA ANDA203364 by RISING

The FDA has granted an approval status of 'AP' for the ANDA203364 application for MESNA submitted by RISING.

RegulatoryAugust 18, 2026

FDA Approval Status for Levetiracetam ANDA091291 by Chartwell RX

The FDA has granted an approval status of 'AP' for the ANDA091291 application for Levetiracetam submitted by Chartwell RX.

RegulatoryAugust 17, 2026

FDA Approval Status for Eltrombopag Olamine by Hikma

The FDA has granted an approval status of 'AP' for Hikma's ANDA220033 application for Eltrombopag Olamine, a treatment for thrombocytopenia. This application is currently in the regulatory approval phase, with a standard review priority.

RegulatoryAugust 17, 2026

Bionpharma receives FDA AP status for Valproic Acid supplement

Bionpharma's application ANDA073484 for a supplement of Valproic Acid has received FDA approval status (AP).

RegulatoryAugust 17, 2026

FDA Approval Status for Haloperidol ANDA071130 by AIPING PHARM INC.

The FDA has an active application (ANDA071130) for Haloperidol submitted by AIPING PHARM INC., currently under AP status. This application indicates that AIPING PHARM INC. is seeking to introduce a generic version of Haloperidol, a well-established antipsychotic medication.

RegulatoryAugust 17, 2026

FDA Approval of Ofloxacin ANDA218557 by Micro Labs

The FDA has approved the ANDA218557 application for Ofloxacin submitted by Micro Labs, with a standard review priority.

RegulatoryAugust 17, 2026

Glenmark Pharmaceuticals receives FDA approval for Progesterone ANDA216363

Glenmark Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA216363) for Progesterone. This approval allows Glenmark to enter the hormonal therapy market, specifically targeting hormone replacement therapy and fertility treatment sectors.

RegulatoryAugust 17, 2026

Hikma's Ondansetron Hydrochloride Supplement Receives FDA Approval

The FDA has approved the supplemental application ANDA076781 for Ondansetron Hydrochloride submitted by Hikma Farmaceutica.

RegulatoryAugust 17, 2026

FDA Approval Status for Emtricitabine and Tenofovir Alafenamide Fumarate by Macleods

The FDA has assigned an Approval Pending (AP) status for ANDA214216, a generic application for Emtricitabine and Tenofovir Alafenamide Fumarate submitted by Macleods Pharmaceuticals.

StrategyAugust 17, 2026

FDA Approval Status for Dapagliflozin ANDA211467 by Micro Labs

The FDA has granted approval status (AP) for ANDA211467, a generic application for Dapagliflozin submitted by Micro Labs.

StrategyAugust 17, 2026

FDA Approves Dapagliflozin ANDA211470 from Biocon Pharma

The FDA has approved the Abbreviated New Drug Application ANDA211470 for Dapagliflozin submitted by Biocon Pharma.

RegulatoryAugust 17, 2026

FDA Approval Status for Dapagliflozin ANDA211478 by MSN

The FDA has assigned an approval status of 'AP' for ANDA211478, a generic application for Dapagliflozin submitted by MSN.

RegulatoryAugust 17, 2026

FDA Approves Dapagliflozin and Metformin Hydrochloride for ANDA211479

The FDA has approved the ANDA211479 application for Dapagliflozin and Metformin Hydrochloride, submitted by MSN.

RegulatoryAugust 17, 2026

FDA Approval Application for Dapagliflozin by Inventia

The FDA has received an approval application (ANDA211156) for Dapagliflozin from Inventia, classified as a standard review.

RegulatoryAugust 17, 2026

FDA Approval Application for Dapagliflozin Submitted by Aizant

Aizant has submitted an original application (ANDA211523) for dapagliflozin, which is currently under standard review by the FDA.

RegulatoryAugust 16, 2026

FDA Approval Status for Dapagliflozin ANDA211560 by Alembic

The FDA has assigned an approval status of AP to Alembic's ANDA211560 for Dapagliflozin.

RegulatoryAugust 16, 2026

Cipla's ANDA211595 for Dapagliflozin and Metformin Approved by FDA

Cipla received FDA approval for ANDA211595, a combination of Dapagliflozin and Metformin Hydrochloride.

StrategyAugust 16, 2026

Sandoz receives FDA approval for Dapagliflozin ANDA211312

Sandoz has received FDA approval for its Abbreviated New Drug Application (ANDA211312) for Dapagliflozin.

RegulatoryAugust 15, 2026

FDA Approves Supplemental Application for Janumet XR

The FDA has approved a supplemental application for Janumet XR, a combination of metformin hydrochloride and sitagliptin phosphate, submitted by Merck.

RegulatoryAugust 15, 2026

FDA Approves Supplemental Application for SYNJARDY by Boehringer Ingelheim

The FDA has approved a supplemental application for SYNJARDY (NDA206111), containing empagliflozin and metformin hydrochloride, submitted by Boehringer Ingelheim.

RegulatoryAugust 15, 2026

FDA Approves Supplement for HEPZATO by Delcath Systems

The FDA has approved a supplemental application for HEPZATO (melphalan hydrochloride) submitted by Delcath Systems.

RegulatoryAugust 15, 2026

FDA Approval Status Update for Actoplus Met by Takeda

The FDA has issued an approval status update for NDA021842, a supplemental application for Actoplus Met, containing metformin hydrochloride and pioglitazone hydrochloride.

RegulatoryAugust 14, 2026

FDA Approves Supplement for SEGLUROMET (Ertugliflozin/Metformin)

The FDA has approved a supplemental application for SEGLUROMET, a combination of ertugliflozin and metformin, submitted by MSD Sub Merck.

RegulatoryAugust 14, 2026

Takeda's Kazano Supplement Application Approved by FDA

The FDA has approved the supplemental application for Kazano (Alogliptin Benzoate and Metformin Hydrochloride) submitted by Takeda Pharmaceuticals USA.

RegulatoryAugust 14, 2026

FDA Approval Status for Flurbiprofen ANDA074431 by New HeightsRx

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Flurbiprofen submitted by New HeightsRx.

RegulatoryAugust 13, 2026

FDA Approval Process for Romidepsin Application ANDA219099

The FDA is reviewing ANDA219099 for Romidepsin submitted by Amneal, with a standard review priority.

RegulatoryAugust 13, 2026

FDA Approval Process for Eribulin Mesylate by NATCO

NATCO has submitted an original application (ANDA217085) for Eribulin Mesylate, currently under standard review by the FDA.

RegulatoryAugust 13, 2026

FDA Approval Application for Mycophenolate Mofetil by Concord Biotech

Concord Biotech Ltd. has submitted an original application (ANDA218566) for Mycophenolate Mofetil, which is currently under standard review by the FDA.

RegulatoryAugust 12, 2026

FDA Approval Process for PHYTONADIONE by AMNEAL

The FDA is reviewing ANDA217734 for PHYTONADIONE submitted by AMNEAL, with a standard review priority.

RegulatoryAugust 12, 2026

FDA Approval Process for Cyclosporine by Jiangsu Anbison

The FDA is reviewing ANDA219288 for cyclosporine submitted by Jiangsu Anbison, with a standard review priority.

RegulatoryAugust 12, 2026

FDA Approval Application for Morphine Sulfate by Fresenius Kabi USA

Fresenius Kabi USA submitted an NDA for Morphine Sulfate (NDA204223) with a standard review priority.

RegulatoryAugust 11, 2026

FDA Approval Application for Deflazacort Submitted by Carnegie

Carnegie has submitted an original application (ANDA220709) for Deflazacort, currently under standard review by the FDA.

RegulatoryAugust 11, 2026

FDA approves supplemental application for CARBIDOPA and LEVODOPA by Rubicon Research

The FDA has approved the supplemental application ANDA217482 for CARBIDOPA and LEVODOPA submitted by Rubicon Research. This approval allows Rubicon to market its formulation in the Parkinson's Disease treatment space, where CARBIDOPA and LEVODOPA are already established therapies.

RegulatoryAugust 11, 2026

FDA Approval Process Update for Clindamycin Phosphate by Almaject

The FDA has updated the submission status for ANDA062801, a supplemental application for Clindamycin Phosphate submitted by Almaject, indicating it is under standard review.

RegulatoryAugust 11, 2026

FDA Approval Application for Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride by Lupin

Lupin has submitted an Abbreviated New Drug Application (ANDA 216095) for a combination product containing Sodium Sulfate, Magnesium Sulfate, and Potassium Chloride, currently under standard review by the FDA.

RegulatoryAugust 11, 2026

FDA Approval Status for Zydus' Oxcarbazepine Supplement

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of AP for Zydus' oxcarbazepine supplement.

RegulatoryAugust 11, 2026

Fresenius Kabi USA Receives FDA Approval for Nicardipine Hydrochloride Injection

Fresenius Kabi USA has received FDA approval for Nicardipine Hydrochloride Injection in 0.9% Sodium Chloride under application ANDA219334. This approval allows Fresenius Kabi to enter the injectable antihypertensive market, where Nicardipine is utilized for managing hypertension.

RegulatoryAugust 11, 2026

FDA Approval Process Update for Linagliptin by Teva Pharmaceuticals

Teva Pharmaceuticals has submitted an original application (ANDA208433) for Linagliptin, DPP-4 inhibitor for type 2 diabetes, which is currently under standard review by the FDA.

StrategyAugust 11, 2026

Hikma's Methotrexate Sodium ANDA Approved by FDA

The FDA has approved Hikma's supplemental application ANDA040054 for Methotrexate Sodium.

RegulatoryAugust 11, 2026

FDA Approves Supplement for Methotrexate Sodium by Daito

The FDA has approved supplemental application ANDA213362 for Methotrexate Sodium submitted by Daito, with a standard review priority.

RegulatoryAugust 10, 2026

FDA Approval Application for L-Glutamine by Annora Pharma

Annora Pharma submitted an original application (ANDA219722) for L-Glutamine, currently under standard review by the FDA.

RegulatoryAugust 10, 2026

FDA Approves Differin Epiduo Acne Gel NDA220736 by Galderma

The FDA has approved Differin Epiduo Acne Gel (NDA220736), containing adapalene and benzoyl peroxide, submitted by Galderma Laboratories.

RegulatoryAugust 10, 2026

FDA Approval Application for Lacosamide by Steranco Healthcare

Steranco Healthcare has submitted an original application (ANDA220366) for Lacosamide, which is currently undergoing standard review by the FDA.

RegulatoryAugust 10, 2026

FDA Approval Application for Cleocin by Pfizer

Pfizer submitted an Abbreviated New Drug Application (ANDA) for Cleocin (Clindamycin Palmitate Hydrochloride) with a standard review priority.

RegulatoryAugust 10, 2026

FDA Approves Nebivolol Hydrochloride Supplement by Prinston Inc.

The FDA has approved a supplemental application for Nebivolol Hydrochloride submitted by Prinston Inc.

StrategyAugust 10, 2026

FDA Approves Levothyroxine Sodium Application ANDA216370 by Alembic

The FDA has approved the application ANDA216370 for Levothyroxine Sodium submitted by Alembic.

RegulatoryAugust 9, 2026

FDA Approves Mirtazapine Application ANDA220104 from Micro Labs

The FDA has approved the ANDA220104 application for Mirtazapine submitted by Micro Labs.

RegulatoryAugust 9, 2026

FDA Approval Process Update for Ciprofloxacin Hydrochloride Supplement

The FDA has received a supplement application for Ciprofloxacin Hydrochloride from Teva Pharmaceuticals.

RegulatoryAugust 9, 2026

FDA Approves Supplemental Application for Macitentan by Seasons Biotech

The FDA has approved a supplemental application for Macitentan (ANDA211026) submitted by Seasons Biotech.

RegulatoryAugust 9, 2026

FDA Approves PHESGO (BLA761170) for Subcutaneous Administration

The FDA has approved the supplemental Biologics License Application for PHESGO, a combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for subcutaneous use.

RegulatoryAugust 9, 2026

FDA Approves Supplemental Application for HERCEPTIN HYLECTA

The FDA has approved the supplemental application BLA761106 for HERCEPTIN HYLECTA, which combines trastuzumab and hyaluronidase-oysk.

RegulatoryAugust 9, 2026

FDA Approval Process Update for Glycopyrrolate (ANDA 216910)

The FDA has an active application for Glycopyrrolate (ANDA 216910) submitted by Quagen, currently under standard review.

RegulatoryAugust 9, 2026

FDA Approves Supplement for Irbesartan by Hisun Pharm

The FDA has approved a supplemental application for Irbesartan submitted by Hisun Pharm.

CompetitiveAugust 9, 2026

FDA Approves Tadalafil Application ANDA210329 by Jubilant Generics

The FDA has approved the original application ANDA210329 for Tadalafil submitted by Jubilant Generics.

RegulatoryAugust 8, 2026

FDA Approval Process Update for Lamotrigine ANDA077420

The FDA has accepted the application ANDA077420 for Lamotrigine submitted by RISING, with a standard review priority.

RegulatoryAugust 8, 2026

FDA Approves Gallium Ga-68 Gozetotide for Diagnostic Use

The FDA has granted approval for Gallium Ga-68 Gozetotide under application ANDA219189, submitted by IONETIX.

StrategyAugust 7, 2026

FDA Approval Process for Nicotine Polacrilex by Dr. Reddy's Labs

Reddy's Labs has submitted an application for Nicotine Polacrilex under ANDA215276, currently in the approval process.

RegulatoryAugust 7, 2026

FDA Approval Process Update for Zolpidem Tartrate by Umedica Labs

Umedica Labs has submitted an application for Zolpidem Tartrate (ANDA220717) with a standard review priority.

RegulatoryAugust 6, 2026

FDA Approves Estradiol Application ANDA218214 from Encube

The FDA has approved the ANDA218214 application for estradiol submitted by Encube.

RegulatoryAugust 6, 2026

FDA Approves Levetiracetam in Sodium Chloride by Mylan Labs

The FDA has approved the application ANDA218364 for levetiracetam in sodium chloride submitted by Mylan Labs.

RegulatoryAugust 6, 2026

FDA Approves Orzeyful for Narcolepsy Type 1 Treatment

The FDA has approved Orzeyful (oveporexton) tablets for treating the full range of narcolepsy type 1 symptoms in adults.

RegulatoryAugust 6, 2026

FDA Approves Supplemental Application for KEFLEX (Cephalexin)

The FDA has approved a supplemental application for KEFLEX, an antibiotic with cephalexin as its active ingredient.

RegulatoryAugust 6, 2026

Merck Receives FDA Approval for LIPFENDRA, First Once-Daily Oral PCSK9 Inhibitor

Merck has received U.S. FDA approval for LIPFENDRA, the first once-daily oral PCSK9 inhibitor for reducing LDL-C in adults with hypercholesterolemia.

RegulatoryAugust 6, 2026

FDA Approval Process Update for Paliperidone (ANDA205402)

The FDA has received an application for Paliperidone under ANDA205402, currently in the approval process.

RegulatoryAugust 6, 2026

FDA Approval Process for Brimonidine Tartrate by Micro Labs

The FDA has accepted the application ANDA218558 for Brimonidine Tartrate submitted by Micro Labs.

StrategyAugust 5, 2026

Aurobindo Pharma's Rosuvastatin Calcium Supplement Application Approved by FDA

The FDA has approved Aurobindo Pharma's supplemental application for Rosuvastatin Calcium.

RegulatoryAugust 5, 2026

FDA Approval Letter for Methylprednisolone Supplement

The FDA has issued an approval letter for a supplement to the ANDA040183 application for Methylprednisolone.

RegulatoryAugust 5, 2026

FDA Approves Supplemental Applications for CellCept (Mycophenolate Mofetil)

The FDA has approved supplemental applications for CellCept, indicating ongoing support for its use.

StrategyAugust 5, 2026

FDA Approval Process Update for Capecitabine ANDA204345 by Dr. Reddy's

Reddy's has submitted an Abbreviated New Drug Application (ANDA) for Capecitabine, currently under standard review.

RegulatoryAugust 5, 2026

FDA Approval Status Update for Sertraline Hydrochloride Supplement

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Sertraline Hydrochloride submitted by Heritage Pharma Avet.

RegulatoryAugust 5, 2026

FDA Approves Supplement for Risperidone by Heritage Pharma

The FDA has approved a supplement for the ANDA076228 application for Risperidone submitted by Heritage Pharma.

RegulatoryAugust 4, 2026

FDA Approves Supplement for Leuprolide Acetate by PH Health

The FDA has approved a supplemental application for Leuprolide Acetate submitted by PH Health.

RegulatoryAugust 3, 2026

FDA Approval Process Update for Vasopressin by Sandoz

The FDA has accepted the application ANDA212069 for Vasopressin submitted by Sandoz, with a standard review priority.

RegulatoryAugust 3, 2026

FDA Approves Lamotrigine Supplement Application by Taro

The FDA has approved a supplemental application for lamotrigine submitted by Taro.

RegulatoryAugust 3, 2026

FDA Approves Leucovorin Calcium Supplement Application by Ingenus Pharmaceuticals

The FDA has approved the supplemental application ANDA211132 for Leucovorin Calcium submitted by Ingenus Pharmaceuticals.

RegulatoryAugust 3, 2026

FDA Approval Process Update for Leucovorin Calcium by Hikma

The FDA has an active application (ANDA072733) for Leucovorin Calcium submitted by Hikma, currently under standard review.

RegulatoryAugust 3, 2026

FDA Approval Process Update for Leucovorin Calcium by Hikma

The FDA has an active application for Leucovorin Calcium (ANDA072735) submitted by Hikma, currently under standard review.

RegulatoryAugust 3, 2026

FDA Approves Leucovorin Calcium Supplement Application by Barr

The FDA has approved the supplemental application for Leucovorin Calcium submitted by Barr.

RegulatoryAugust 3, 2026

FDA Approval Process Update for Leucovorin Calcium by Barr

The FDA has an active application (ANDA071199) for Leucovorin Calcium submitted by Barr, currently under standard review.

RegulatoryAugust 3, 2026

FDA Approval Status for Leucovorin Calcium Supplement

The FDA has granted an approval status of 'AP' for ANDA213929, a supplement for Leucovorin Calcium.

RegulatoryAugust 3, 2026

FDA Approval Process Update for Ondansetron Hydrochloride Preservative Free

The FDA has updated the submission status for ANDA078945 for Ondansetron Hydrochloride Preservative Free to Approved (AP).

RegulatoryAugust 3, 2026

FDA Approval Process Update for Perphenazine by Zydus Pharmaceuticals

The FDA has an active application (ANDA205232) for Perphenazine submitted by Zydus Pharmaceuticals, currently under review.

RegulatoryAugust 3, 2026

FDA Approves JAKAFI XR (Ruxolitinib Phosphate) Submission by Incyte

The FDA has approved the New Drug Application (NDA) for JAKAFI XR, a formulation of ruxolitinib phosphate, submitted by Incyte Corporation.

RegulatoryAugust 3, 2026

FDA Approves Propranolol Hydrochloride Application ANDA203103

The FDA has approved the ANDA203103 application for Propranolol Hydrochloride submitted by IPCA Labs Ltd.

RegulatoryAugust 3, 2026

FDA Approval Status Update for Calcium Acetate by Chartwell Molecular

The FDA has granted an Approval Pending (AP) status for ANDA202420, a supplemental application for Calcium Acetate submitted by Chartwell Molecular.

RegulatoryAugust 3, 2026

FDA Approves Torsemide Application ANDA217239 from Micro Labs

The FDA has approved the ANDA217239 application for Torsemide submitted by Micro Labs.

RegulatoryAugust 3, 2026

FDA Approves Supplement for Deutetrabenazine by Aurobindo Pharma

The FDA has approved a supplemental application for deutetrabenazine submitted by Aurobindo Pharma.

RegulatoryAugust 2, 2026

FDA Approval Application for Mirabegron Submitted by Deva Holding

The FDA has received an application (ANDA219941) for Mirabegron from Deva Holding, currently under standard review.

RegulatoryAugust 2, 2026

FDA Approval Process Update for Mycophenolate Sodium by Yichang Humanwell

The FDA has accepted the application ANDA214376 for Mycophenolate Sodium submitted by Yichang Humanwell, with a standard review priority.

RegulatoryAugust 2, 2026

FDA Approves Supplement for Gadobutrol by Hengrui Pharma

The FDA has approved a supplemental application for Gadobutrol submitted by Hengrui Pharma.

RegulatoryAugust 2, 2026

FDA Approves Glycerol Phenylbutyrate Application by Lupin

The FDA has approved the application ANDA207694 for Glycerol Phenylbutyrate submitted by Lupin.

RegulatoryAugust 2, 2026

FDA Approves Pregabalin Application ANDA219593 by Unichem

The FDA has approved the ANDA219593 application for Pregabalin submitted by Unichem.

StrategyAugust 2, 2026

FDA Approves Sitagliptin and Metformin Hydrochloride Combination

The FDA has approved the combination of Sitagliptin and Metformin Hydrochloride under application ANDA202426 by Apotex.

RegulatoryAugust 2, 2026

FDA Approves Supplemental Application for Perseris Kit by Indivior

The FDA has approved a supplemental application for the Perseris Kit, which contains risperidone.

RegulatoryAugust 2, 2026

FDA Approves Methotrexate Sodium Application ANDA219865

The FDA has approved the application ANDA219865 for Methotrexate Sodium submitted by Hetero Labs Ltd.

RegulatoryAugust 2, 2026

FDA Approves Lutetium Lu 177 VIPIVOTIDE for Metastatic Prostate Cancer

The FDA has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) for use in combination with androgen receptor pathway inhibitors in adults with PSMA-positive metastatic prostate cancer.

RegulatoryAugust 2, 2026

FDA Approves Supplemental Application for MYFORTIC by Novartis

The FDA has approved a supplemental application for MYFORTIC, an immunosuppressant used in renal transplantation.

RegulatoryAugust 2, 2026

FDA Approves Supplement for VEKLURY (Remdesivir) by Gilead Sciences

The FDA has approved a supplemental application for VEKLURY (remdesivir) submitted by Gilead Sciences.

RegulatoryAugust 2, 2026

FDA Approves QLONILIK (Clonidine Hydrochloride) NDA221094

The FDA has approved QLONILIK, containing Clonidine Hydrochloride, under NDA221094.

RegulatoryAugust 2, 2026

FDA Approves Supplement for CellCept (Mycophenolate Mofetil) by Roche

The FDA has approved a supplemental application for CellCept, a drug containing mycophenolate mofetil hydrochloride, submitted by Roche.

RegulatoryAugust 2, 2026

FDA Approval Status Update for Mycophenolate Mofetil by Hikma

The FDA has issued an approval status update for Hikma's ANDA065410 concerning Mycophenolate Mofetil.

StrategyAugust 2, 2026

FDA Approval Update for Mycophenolate Mofetil by Hikma

Hikma has received an approval status for their ANDA submission for Mycophenolate Mofetil.

RegulatoryAugust 2, 2026

FDA Approval Status Update for Mycophenolate Sodium by RK Pharma

RK Pharma's application for Mycophenolate Sodium has received an approval status update from the FDA.

StrategyAugust 1, 2026

FDA Approves ANDA for Mycophenolate Mofetil by Hetero Labs

The FDA has approved ANDA208119 for Mycophenolate Mofetil submitted by Hetero Labs.

StrategyAugust 1, 2026

FDA Approves ANDA207022 for Mycophenolate Mofetil by Hetero Labs

The FDA has approved ANDA207022 for Mycophenolate Mofetil submitted by Hetero Labs.

RegulatoryAugust 1, 2026

FDA Approves Mycophenolate Mofetil Hydrochloride Supplement Application

The FDA has approved the supplemental application for Mycophenolate Mofetil Hydrochloride submitted by BPI Labs.

RegulatoryAugust 1, 2026

FDA Approval of Ciclopirox Supplement by Sun Pharma Canada

The FDA has approved a supplement for Ciclopirox submitted by Sun Pharma Canada.

RegulatoryAugust 1, 2026

FDA Approves Supplement for Cytarabine by Hospira

The FDA has approved a supplemental application for Cytarabine submitted by Hospira.

RegulatoryAugust 1, 2026

Teva's Sugammadex Sodium Receives FDA Approval Status

Teva Pharmaceuticals has received an Abbreviated New Drug Application (ANDA) approval status for Sugammadex Sodium.

CompetitiveAugust 1, 2026

Dr. Reddy's Sugammadex Sodium ANDA214236 Receives FDA Approval

Reddy's has received FDA approval for Sugammadex Sodium under ANDA214236.

StrategyAugust 1, 2026

Sandoz Receives FDA Approval for Sugammadex Sodium (ANDA214311)

Sandoz has received an Abbreviated New Drug Application (ANDA) approval for Sugammadex Sodium.

RegulatoryAugust 1, 2026

FDA Approves Sugammadex Sodium for Gland Pharma

The FDA has approved Sugammadex Sodium under application ANDA214364 submitted by Gland Pharma.

RegulatoryAugust 1, 2026

FDA Approves Supplement for HETLIOZ (Tasimelteon) by Vanda Pharmaceuticals

The FDA has approved a supplemental application for HETLIOZ, a drug containing tasimelteon.

RegulatoryAugust 1, 2026

Impax Labs Receives FDA Approval for Metformin Hydrochloride Supplement

Impax Labs has received an Abbreviated New Drug Application (ANDA) approval for a supplement of Metformin Hydrochloride.

RegulatoryAugust 1, 2026

FDA Approves Supplement for Methylphenidate by Mylan Tech Viatris

The FDA has approved a supplemental application for Methylphenidate submitted by Mylan Tech Viatris.

RegulatoryAugust 1, 2026

FDA Approval Process Update for OXCARBAZEPINE by UMEDICA LABS

UMEDICA LABS has submitted an original application for OXCARBAZEPINE, currently under standard review.

RegulatoryAugust 1, 2026

FDA Approval Process Update for Methylphenidate Hydrochloride by Rising

The FDA has accepted the supplemental application ANDA205756 for Methylphenidate Hydrochloride submitted by Rising.

RegulatoryJuly 31, 2026

FDA Approval Status Update for Carbamazepine ANDA205571 by Zydus Pharmaceuticals

The FDA has granted an approval status of 'AP' for ANDA205571, a supplemental application for Carbamazepine by Zydus Pharmaceuticals.

RegulatoryJuly 31, 2026

FDA Approval Process Update for Gabapentin ANDA214957

The FDA is reviewing ANDA214957 for Gabapentin submitted by Ascent Pharms Inc. under standard review priority.

RegulatoryJuly 31, 2026

FDA Approves Eltrombopag Olamine Application by Biocon Pharma

The FDA has approved the application ANDA220660 for Eltrombopag Olamine submitted by Biocon Pharma.

RegulatoryJuly 31, 2026

EUGIA PHARMA's Tranexamic Acid Supplement Receives FDA AP Status

EUGIA PHARMA's application for a supplement of Tranexamic Acid has received FDA approval status.

RegulatoryJuly 31, 2026

FDA Approves Supplement for Atorvastatin Calcium by Sciegen Pharmaceuticals

The FDA has approved a supplemental application for atorvastatin calcium submitted by Sciegen Pharmaceuticals.

RegulatoryJuly 31, 2026

FDA Approves Doxepin Hydrochloride Application by Sun Pharma

The FDA has approved the application ANDA213919 for Doxepin Hydrochloride submitted by Sun Pharma.

RegulatoryJuly 31, 2026

FDA Approves Pomalidomide Supplement by Breckenridge

The FDA has approved a supplemental application for Pomalidomide submitted by Breckenridge.

RegulatoryJuly 31, 2026

FDA Approves Afamitresgene Autoleucel for Synovial Sarcoma, Highlighting TCR Therapy Advances

The FDA has granted accelerated approval for afamitresgene autoleucel, TCR therapy targeting MAGE-A4 in synovial sarcoma.

RegulatoryJuly 31, 2026

FDA Approves Lenalidomide Supplement by Zydus Pharmaceuticals

The FDA has approved a supplemental application for lenalidomide submitted by Zydus Pharmaceuticals.

RegulatoryJuly 31, 2026

FDA Approves Lenalidomide Supplement Application by Sun Pharma

The FDA has approved the supplemental application ANDA211846 for lenalidomide submitted by Sun Pharma.

RegulatoryJuly 31, 2026

FDA Approval Process Update for Prednisolone ANDA219509

The FDA is currently processing the ANDA219509 application for Prednisolone submitted by TP ANDA Holdings.

StrategyJuly 31, 2026

FDA Approves Lenalidomide ANDA217554 Submission by Deva Holding AS

The FDA has approved the ANDA217554 submission for Lenalidomide by Deva Holding AS.

RegulatoryJuly 30, 2026

Cipla's Lenalidomide ANDA214618 Receives FDA AP Status

Cipla's ANDA214618 for Lenalidomide has received FDA approval status (AP) for its supplemental application.

RegulatoryJuly 30, 2026

FDA Approves Ticagrelor Application ANDA208539 by Micro Labs

The FDA has approved the original application for Ticagrelor (ANDA208539) submitted by Micro Labs.

StrategyJuly 30, 2026

FDA Approves Lamotrigine ANDA206382 Submission by Sciegen Pharmaceuticals

The FDA has accepted the Abbreviated New Drug Application (ANDA) for lamotrigine submitted by Sciegen Pharmaceuticals.

StrategyJuly 30, 2026

FDA Approves LYTENAVA (BLA761320) from Outlook Therapeutics

The FDA has approved LYTENAVA (BLA761320), a new formulation of Bevacizumab by Outlook Therapeutics.

RegulatoryJuly 30, 2026

FDA Approval Update for Meridian Bioscience's NDA021314

The FDA has accepted the application NDA021314 from Meridian Bioscience for review.

RegulatoryJuly 30, 2026

FDA Approves Supplemental Application for Brexafemme (Ibrexafungerp) by GlaxoSmithKline

The FDA has approved a supplemental application for Brexafemme, an antifungal treatment.

StrategyJuly 30, 2026

FDA Approves Metformin Hydrochloride ANDA077064 by Zydus Pharms USA

The FDA has granted approval for ANDA077064, a generic version of Metformin Hydrochloride by Zydus Pharms USA.

RegulatoryJuly 30, 2026

Lupin's Lenalidomide ANDA214398 Receives FDA Approval Status

Lupin's application ANDA214398 for lenalidomide has received an approval status from the FDA.

StrategyJuly 30, 2026

FDA Approves Fingolimod Hydrochloride Application by Alembic

The FDA has granted approval for the ANDA207974 application for Fingolimod Hydrochloride submitted by Alembic.

RegulatoryJuly 29, 2026

FDA Approves Supplemental Application for Ziprasidone Hydrochloride

The FDA has approved a supplemental application for Ziprasidone Hydrochloride submitted by Chartwell RX.

RegulatoryJuly 29, 2026

FDA Approval Update for Meridian Bioscience's NDA021314

The FDA has accepted the NDA021314 submission from Meridian Bioscience for review.

RegulatoryJuly 29, 2026

FDA Approves Supplemental NDA for ZIAC by Teva

The FDA has approved a supplemental NDA for ZIAC, which contains bisoprolol fumarate and hydrochlorothiazide.

RegulatoryJuly 29, 2026

FDA Approves LYTENAVA (BLA761320) for Use

The FDA has approved LYTENAVA, a new formulation of bevacizumab, under application BLA761320.

RegulatoryJuly 29, 2026

FDA Approves Supplemental Application for KALETRA by AbbVie

The FDA has approved a supplemental application for KALETRA, a combination of Lopinavir and Ritonavir, submitted by AbbVie.

StrategyJuly 29, 2026

FDA Approves ANDA for Verapamil Hydrochloride by Knack

The FDA has approved the ANDA220076 for Verapamil Hydrochloride submitted by Knack.

RegulatoryJuly 29, 2026

FDA Approves JIDEYTRO (ZIDESAMTINIB) for Nuvalent Inc.

The FDA has approved JIDEYTRO (ZIDESAMTINIB) under NDA220185 submitted by Nuvalent Inc.

RegulatoryJuly 29, 2026

FDA Approval Update for AUGMENTIN '875' Submission

The FDA has accepted a supplemental application for AUGMENTIN '875' from US ANTIBIOTICS.

RegulatoryJuly 29, 2026

FDA Approval Status for Valsartan and Hydrochlorothiazide by Sciegen Pharms

The FDA has granted approval status (AP) for ANDA204687, a combination of Valsartan and Hydrochlorothiazide by Sciegen Pharms.

RegulatoryJuly 29, 2026

FDA Approval Process Update for Alendronate Sodium by Impax Labs

The FDA has an active application (ANDA075710) for Alendronate Sodium submitted by Impax Labs, currently under standard review.

RegulatoryJuly 28, 2026

Cipla's Albuterol Sulfate ANDA219409 Receives FDA Approval Status

Cipla's application for Albuterol Sulfate (ANDA219409) has received an approval status of AP from the FDA.

StrategyJuly 28, 2026

FDA Approves Escitalopram Oxalate Application by Micro Labs

The FDA has approved the ANDA091655 application for Escitalopram Oxalate submitted by Micro Labs.

RegulatoryJuly 28, 2026

FDA Approval Process Update for Tolvaptan by Alkem Labs

The FDA has received an application (ANDA220147) for Tolvaptan from Alkem Labs, currently under standard review.

RegulatoryJuly 28, 2026

Impax Labs receives FDA approval for Methylphenidate Hydrochloride supplement

Impax Labs has received an Abbreviated New Drug Application (ANDA) approval for a supplement related to Methylphenidate Hydrochloride.

RegulatoryJuly 28, 2026

Aurobindo Pharma's Pirfenidone Receives FDA Approval Status Update

Aurobindo Pharma's application for Pirfenidone (ANDA212597) has received an approval status update from the FDA.

StrategyJuly 28, 2026

FDA Approves Canagliflozin Application by Aurobindo Pharma

The FDA has approved the ANDA210386 application for Canagliflozin submitted by Aurobindo Pharma.

RegulatoryJuly 28, 2026

FDA Approves Sodium Acetate Application ANDA220274 by Extrovis

The FDA has approved the application ANDA220274 for Sodium Acetate submitted by Extrovis.

RegulatoryJuly 27, 2026

FDA Approves Supplement for Valproic Acid by Quagen

The FDA has approved a supplemental application for Valproic Acid submitted by Quagen.

RegulatoryJuly 27, 2026

FDA Approves Brimonidine Tartrate Application ANDA220398 by Mankind Pharma

The FDA has approved the application ANDA220398 for Brimonidine Tartrate submitted by Mankind Pharma.

RegulatoryJuly 27, 2026

FDA Approves Aurobindo's Dextromethorphan Polistirex Application

The FDA has approved Aurobindo Pharma's application for Dextromethorphan Polistirex under ANDA218417.

RegulatoryJuly 27, 2026

FDA Approves Atropine Sulfate Application ANDA219013 by Edenbridge Pharms

The FDA has approved the ANDA219013 application for Atropine Sulfate submitted by Edenbridge Pharms.

StrategyJuly 27, 2026

Aurobindo Pharma's Alendronate Sodium Supplement Application Approved by FDA

The FDA has approved the supplemental application ANDA090124 for Alendronate Sodium submitted by Aurobindo Pharma.

RegulatoryJuly 27, 2026

FDA Approves Ondansetron Hydrochloride Preservative Free Supplement

The FDA has approved the supplement application for Ondansetron Hydrochloride Preservative Free by ONESOURCE SPECIALTY.

RegulatoryJuly 26, 2026

FDA Approval Status Update for Ondansetron Hydrochloride Supplement

The FDA has granted an approval status (AP) for the Ondansetron Hydrochloride supplement submitted by Onesource Specialty.

RegulatoryJuly 26, 2026

FDA Grants Approval for Glycerol Phenylbutyrate by Teva Pharmaceuticals

Teva Pharmaceuticals has received FDA approval for Glycerol Phenylbutyrate under application ANDA218738.

RegulatoryJuly 26, 2026

FDA Approval Process Update for Lactulose by Cumberland Pharmaceuticals

The FDA has an active application for Lactulose (ANDA074712) submitted by Cumberland Pharmaceuticals, currently under standard review.

RegulatoryJuly 26, 2026

FDA Approves Supplemental Application for Milnacipran Hydrochloride

The FDA has approved a supplemental application for Milnacipran Hydrochloride submitted by Breckenridge.

RegulatoryJuly 26, 2026

FDA Approval Process Update for Lamotrigine by Alembic Pharmaceuticals

Alembic Pharmaceuticals has submitted a supplemental application for Lamotrigine, currently under standard review.

StrategyJuly 26, 2026

FDA Approves Pimozide Application ANDA219897 from Novitium Pharma

The FDA has approved the application ANDA219897 for Pimozide submitted by Novitium Pharma.

RegulatoryJuly 26, 2026

FDA Approval Process for Olmesartan Medoxomil and Hydrochlorothiazide by Micro Labs

The FDA has received an application for Olmesartan Medoxomil and Hydrochlorothiazide from Micro Labs, currently under standard review.

RegulatoryJuly 25, 2026

FDA Approves Cangrelor for Market Release

The FDA has granted approval for Cangrelor under application ANDA213703, submitted by MSN.

RegulatoryJuly 25, 2026

FDA Approves Supplemental Application for Children's Allegra Hives

The FDA has approved a supplemental application for Children's Allegra Hives, containing fexofenadine hydrochloride.

RegulatoryJuly 25, 2026

FDA Approves Augmentin '875' Supplement Application

The FDA has approved a supplemental application for Augmentin '875' submitted by US Antibiotics.

RegulatoryJuly 25, 2026

FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer

The FDA has approved zidesamtinib for adults with ROS1-positive NSCLC after prior TKI treatment.

StrategyJuly 25, 2026

FDA Approves First Nonprescription Acetaminophen and Naproxen Combination for Pain Relief

The FDA has approved Tylenol with Naproxen, a fixed-dose combination for 12-hour pain relief.

StrategyJuly 25, 2026

FDA Approval Update for Ciprofloxacin Hydrochloride by Hikma

Hikma has received an Abbreviated New Drug Application (ANDA) approval for Ciprofloxacin Hydrochloride.

StrategyJuly 24, 2026

FDA Approves ANDA for Carfilzomib by MSN

The FDA has approved the ANDA209526 application for Carfilzomib submitted by MSN.

RegulatoryJuly 24, 2026

FDA Approves Supplemental Application for INREBIC (Fedratinib Hydrochloride)

The FDA has approved a supplemental application for INREBIC, a treatment for myelofibrosis.

RegulatoryJuly 24, 2026

FDA Approval Status Update for Doxepin Hydrochloride by Mylan

The FDA has granted an approval status (AP) for the supplemental application ANDA070791 for Doxepin Hydrochloride submitted by Mylan.

RegulatoryJuly 24, 2026

FDA Approves Ferric Carboxymaltose for Mylan's ANDA217076

The FDA has approved Mylan's application for Ferric Carboxymaltose under ANDA217076.

RegulatoryJuly 24, 2026

FDA Approves Supplemental Application for OGSIVEO (Nirogacestat Hydro bromide)

The FDA has approved a supplemental application for OGSIVEO, containing Nirogacestat Hydrobromide.

RegulatoryJuly 24, 2026

FDA Approval Update for Azathioprine Supplement by Rising

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for a supplement of Azathioprine by Rising.

RegulatoryJuly 23, 2026

FDA Approves Supplemental Application for PURIXAN by Nova Labs

The FDA has approved a supplemental application for PURIXAN, an antimetabolite containing mercaptopurine, submitted by Nova Labs.

RegulatoryJuly 23, 2026

FDA Approves Supplement for PHEBURANE (NDA216513) by MEDUNIK

The FDA has approved a supplemental application for PHEBURANE, a treatment containing sodium phenylbutyrate.

RegulatoryJuly 23, 2026

FDA Approval Update for Acetazolamide Supplement by Heritage Pharma

Heritage Pharma has received an approval update for a supplement application for Acetazolamide.

StrategyJuly 23, 2026

FDA Approves Metformin Hydrochloride ANDA075961 from Watson Labs

The FDA has approved the Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride submitted by Watson Labs.

RegulatoryJuly 23, 2026

FDA Approves Supplemental Applications for ZYBAN by GlaxoSmithKline

The FDA has approved supplemental applications for ZYBAN (bupropion hydrochloride) submitted by GlaxoSmithKline.

RegulatoryJuly 23, 2026

FDA Approval Update for Norethindrone Acetate and Ethinyl Estradiol

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for a combination product containing Norethindrone Acetate and Ethinyl Estradiol.

RegulatoryJuly 23, 2026

FDA Approves Supplement for Buprenorphine Hydrochloride by Rubicon Research

The FDA has approved a supplemental application for Buprenorphine Hydrochloride submitted by Rubicon Research.

RegulatoryJuly 23, 2026

FDA Approves Supplemental Application for QTERN (Dapagliflozin/Saxagliptin)

The FDA has approved a supplemental application for QTERN, a combination of dapagliflozin and saxagliptin.

RegulatoryJuly 23, 2026

FDA Approves Supplemental Application for Farxiga (Dapagliflozin)

The FDA has approved a supplemental application for Farxiga, an SGLT2 inhibitor developed by AstraZeneca.

StrategyJuly 23, 2026

FDA Approves ANDA for Tofacitinib Citrate by Sun Pharma

The FDA has granted approval for ANDA218407, a generic version of Tofacitinib Citrate submitted by Sun Pharma.

StrategyJuly 23, 2026

FDA Approves Breckenridge's Tofacitinib Citrate Application

The FDA has approved Breckenridge's application for Tofacitinib Citrate under ANDA209633.

RegulatoryJuly 22, 2026

FDA Approval Letter for Tofacitinib Citrate by Micro Labs

The FDA has issued an approval letter for ANDA209738 for Tofacitinib Citrate submitted by Micro Labs.

RegulatoryJuly 22, 2026

Sandoz submits ANDA for Pemigatinib, seeking FDA approval

Sandoz Inc. has submitted an Abbreviated New Drug Application (ANDA) for Pemigatinib, currently under standard review.

RegulatoryJuly 22, 2026

FDA Approves Supplement for ULTOMIRIS (Ravulizumab-Cwvz)

The FDA has approved a supplemental application for ULTOMIRIS, indicating a significant regulatory milestone for Alexion Pharmaceuticals.

RegulatoryJuly 21, 2026

FDA Approval Letter for Morphine Sulfate by Fresenius Kabi USA

The FDA has issued an approval letter for the supplemental application of Morphine Sulfate (NDA204223) submitted by Fresenius Kabi USA.

RegulatoryJuly 21, 2026

FDA Approves Supplement for Voriconazole by Hainan Poly Pharm

The FDA has approved a supplemental application for Voriconazole submitted by Hainan Poly Pharm.

RegulatoryJuly 21, 2026

FDA Approval Update for OXCARBAZEPINE by Glenmark Pharmaceuticals

The FDA has accepted the supplemental application for OXCARBAZEPINE submitted by Glenmark Pharmaceuticals.

RegulatoryJuly 21, 2026

FDA Approves Supplement for HEPZATO by Delcath Systems

The FDA has approved a supplemental application for HEPZATO, containing melphalan hydrochloride.

RegulatoryJuly 20, 2026

FDA Approves Supplemental Application for Methotrexate Sodium by Hikma

The FDA has approved a supplemental application for Methotrexate Sodium submitted by Hikma.

RegulatoryJuly 20, 2026

FDA Approval Update for TREXALL (Methotrexate Sodium) by Barr

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for TREXALL, a methotrexate sodium product by Barr.

StrategyJuly 20, 2026

FDA Approval Application for Linagliptin by Teva Pharmaceuticals

Teva Pharmaceuticals has submitted an original application for Linagliptin under ANDA208433 with a standard review priority.

RegulatoryJuly 20, 2026

FDA Approves Differin Epiduo Acne Gel for Acne Treatment

The FDA has approved Differin Epiduo Acne Gel, which contains adapalene and benzoyl peroxide.

RegulatoryJuly 20, 2026

FDA Approves Supplemental Application for TYENNE (Tocilizumab-AAZG)

The FDA has approved a supplemental application for TYENNE, a formulation of Tocilizumab-AAZG, submitted by Fresenius Kabi USA.

RegulatoryJuly 20, 2026

FDA Approval Status Update for Cleocin (Clindamycin Palmitate Hydrochloride)

The FDA has updated the submission status for Cleocin, indicating an Abbreviated New Drug Application (ANDA) approval process.

RegulatoryJuly 20, 2026

FDA Approves Supplement for Biktarvy by Gilead Sciences

The FDA has approved a supplemental application for Biktarvy, a combination therapy for HIV.

StrategyJuly 20, 2026

FDA Approves ANDA for Lacosamide by Steranco Healthcare

The FDA has granted approval for ANDA220366, a generic version of lacosamide, submitted by Steranco Healthcare.

RegulatoryJuly 19, 2026

FDA Approves Supplement for NYVEPRIA (PEGFILGRASTIM-APGF)

The FDA has approved a supplemental application for NYVEPRIA, a pegfilgrastim product.

StrategyJuly 19, 2026

FDA Approves Clonazepam ANDA216988 from Rubicon Research

The FDA has approved ANDA216988 for Clonazepam submitted by Rubicon Research.

RegulatoryJuly 19, 2026

Granules' ANDA217027 for Amphetamine Products Receives FDA Approval

The FDA has approved ANDA217027 submitted by Granules for a combination of amphetamine products.

RegulatoryJuly 19, 2026

FDA Approval for XYZAL ALLERGY 24HR Supplement Application

The FDA has accepted the supplemental application for XYZAL ALLERGY 24HR, indicating a review of its active ingredient, levocetirizine dihydrochloride.

RegulatoryJuly 19, 2026

FDA Approves Supplemental Application for Children's Claritin

The FDA has approved a supplemental application for Children's Claritin (loratadine) submitted by Bayer Healthcare.

RegulatoryJuly 19, 2026

FDA Approves Supplement for TYENNE (Tocilizumab-AAZG) by Fresenius Kabi

The FDA has approved a supplemental application for TYENNE, a formulation of Tocilizumab-AAZG.

RegulatoryJuly 19, 2026

FDA Approves HERCEPTIN HYLECTA Supplement Application

The FDA has approved the supplemental application for HERCEPTIN HYLECTA, which combines trastuzumab and hyaluronidase.

RegulatoryJuly 19, 2026

FDA Approves PHESGO Supplement for Genentech's Combination Therapy

The FDA has approved a supplemental application for PHESGO, a combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf.

CompetitiveJuly 18, 2026

FDA Approves First Oral PCSK9 Inhibitor Lipfendra for High Cholesterol

The FDA has approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor for lowering LDL cholesterol in adults.

RegulatoryJuly 18, 2026

FDA Approves Supplement for Tegretol (Carbamazepine) by Novartis

The FDA has approved a supplemental application for Tegretol, an antiepileptic drug containing carbamazepine.

RegulatoryJuly 18, 2026

FDA Approves Supplemental Application for Retevmo (Selpercatinib)

The FDA has approved a supplemental application for Retevmo (selpercatinib) submitted by Eli Lilly.

RegulatoryJuly 18, 2026

FDA Approves REVTORPYK (GEDATOLISIB) for Celcuity Inc.

The FDA has approved REVTORPYK (gedatolisib) under NDA219908 for Celcuity Inc.

RegulatoryJuly 18, 2026

Novartis Fabhalta® (iptacopan) gains FDA approval for primary IgAN treatment

Fabhalta® (iptacopan) is the first and only complement inhibitor approved by the FDA to significantly slow kidney function decline in primary IgA nephropathy (IgAN).

RegulatoryJuly 18, 2026

FDA Approves BAXFENDY (BAXDROSTAT) by AstraZeneca

The FDA has approved BAXFENDY (BAXDROSTAT) under NDA219878, indicating a significant milestone for AstraZeneca.

StrategyJuly 18, 2026

Jubilant Generics receives FDA approval for Tadalafil ANDA210329

Jubilant Generics has received an Abbreviated New Drug Application (ANDA) approval for Tadalafil.

RegulatoryJuly 17, 2026

FDA Approves TRIMBOW (NDA219622) by Chiesi

The FDA has approved TRIMBOW, a combination inhaler containing beclomethasone dipropionate, formoterol fumarate, and glycopyrrolate.

RegulatoryJuly 16, 2026

FDA Approves Gallium Ga-68 Gozetotide for Diagnostic Use

The FDA has approved the application ANDA219189 for Gallium Ga-68 Gozetotide, submitted by IONETIX.

RegulatoryJuly 16, 2026

FDA Approves Supplemental Application for Zithromax (Azithromycin)

The FDA has approved a supplemental application for Zithromax (Azithromycin) submitted by Pfizer.

RegulatoryJuly 16, 2026

FDA Approves Supplemental Application for Zithromax by Pfizer

The FDA has approved a supplemental application for Zithromax (azithromycin) submitted by Pfizer.

RegulatoryJuly 16, 2026

FDA Approves Supplemental NDA for Argatroban by Fresenius Kabi

The FDA has approved a supplemental NDA for Argatroban submitted by Fresenius Kabi.

RegulatoryJuly 16, 2026

FDA Approves Supplemental Application for Children's Zyrtec Hives

The FDA has approved a supplemental application for Children's Zyrtec Hives, containing cetirizine hydrochloride.

RegulatoryJuly 16, 2026

FDA Approves Supplemental Application for Zithromax by Pfizer

The FDA has approved a supplemental application for Zithromax (Azithromycin) submitted by Pfizer.

RegulatoryJuly 16, 2026

Sandoz Receives FDA Approval for Metformin Hydrochloride Supplement

Sandoz has received an Abbreviated New Drug Application (ANDA) approval for a supplement of Metformin Hydrochloride.

RegulatoryJuly 16, 2026

FDA Approval Status Update for Buprenorphine Hydrochloride by Rubicon Research

The FDA has an active application (ANDA090279) for Buprenorphine Hydrochloride submitted by Rubicon Research.

StrategyJuly 16, 2026

FDA Approves Original Application for Magnesium Sulfate by Square Pharms PLC

The FDA has approved the original application ANDA217461 for Magnesium Sulfate submitted by Square Pharms PLC.

RegulatoryJuly 15, 2026

FDA Approval Letter for Dextrose 5% in Plastic Container

The FDA has issued an approval letter for the NDA016730 application for Dextrose 5% in a plastic container submitted by B BRAUN.

StrategyJuly 15, 2026

UMEDICA LABS Receives FDA Approval for Zolpidem Tartrate ANDA220717

UMEDICA LABS has received an Abbreviated New Drug Application (ANDA) approval for Zolpidem Tartrate.

StrategyJuly 15, 2026

FDA Approves First Generics of Gilotrif (afatinib) Tablets

The FDA has approved the first generic versions of Gilotrif (afatinib) for treating metastatic NSCLC with specific EGFR mutations.

RegulatoryJuly 15, 2026

FDA approves gedatolisib with fulvestrant for HR-positive, HER2-negative breast cancer

The FDA has approved gedatolisib in combination with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative breast cancer.

RegulatoryJuly 15, 2026

FDA Approval Update for Methylergomovine Maleate by Amneal Pharmaceuticals

The FDA has accepted the supplemental application ANDA211483 for Methylergonovine Maleate submitted by Amneal Pharmaceuticals.

RegulatoryJuly 15, 2026

FDA Approves Selpercatinib for RET Fusion-Positive Solid Tumors

The FDA has granted traditional approval for selpercatinib, targeting locally advanced or metastatic RET fusion-positive solid tumors.

StrategyJuly 14, 2026

FDA Approves Lamotrigine ANDA078625 by Rubicon Research

The FDA has approved ANDA078625 for Lamotrigine submitted by Rubicon Research.

RegulatoryJuly 14, 2026

FDA Approves Supplemental Application for NURTEC ODT by Pfizer

The FDA has approved a supplemental application for NURTEC ODT, an oral medication containing rimegepant sulfate.

RegulatoryJuly 14, 2026

FDA Approves First At-home Starting Dose for Leqembi in Alzheimer's Treatment

The FDA has approved a new starting dosage regimen for Leqembi, allowing for at-home administration.

StrategyJuly 13, 2026

FDA Approval Update for Risperidone by Heritage Pharma

Heritage Pharma has received an Abbreviated New Drug Application (ANDA) approval for Risperidone.

RegulatoryJuly 13, 2026

FDA Approves Supplemental Application for BRILINTA (Ticagrelor)

The FDA has approved a supplemental application for BRILINTA, a medication containing ticagrelor, submitted by AstraZeneca.

RegulatoryJuly 13, 2026

FDA Approves Supplement for Alendronate Sodium by Rising

The FDA has approved a supplemental application for Alendronate Sodium submitted by Rising.

StrategyJuly 13, 2026

FDA Approval for Acetazolamide Sodium by Mylan

The FDA has approved ANDA200880 for Acetazolamide Sodium submitted by Mylan.

RegulatoryJuly 13, 2026

FDA Approves Supplemental Applications for ELIGARD Kit

The FDA has approved supplemental applications for the ELIGARD Kit, which contains leuprolide acetate.

CompetitiveJuly 13, 2026

Sandoz Receives FDA Approval for Vasopressin ANDA212069

Sandoz has received an Abbreviated New Drug Application (ANDA) approval for Vasopressin.

StrategyJuly 13, 2026

Sandoz Receives FDA Approval for Vasopressin ANDA212068

Sandoz's ANDA212068 for Vasopressin has received an Abbreviated Approval from the FDA.

RegulatoryJuly 12, 2026

FDA Approves Supplemental Application for Wegovy (Semaglutide)

The FDA has approved a supplemental application for Wegovy, a drug containing semaglutide, submitted by Novo.

CompetitiveJuly 12, 2026

FDA Approves ANDA for Bupropion Hydrochloride by Yichang Humanwell

The FDA has granted approval for ANDA220529 for Bupropion Hydrochloride submitted by Yichang Humanwell.

RegulatoryJuly 12, 2026

FDA Approves JAKAFI XR for Incyte Corp.

The FDA has approved JAKAFI XR, a formulation of ruxolitinib phosphate, for use.

RegulatoryJuly 12, 2026

FDA Approves ANDA203103 for Propranolol Hydrochloride by IPCA Labs

The FDA has approved ANDA203103 for Propranolol Hydrochloride submitted by IPCA Labs.

StrategyJuly 12, 2026

FDA Approves Varenicline Tartrate ANDA219382 by Somerset Therap LLC

The FDA has approved the ANDA for Varenicline Tartrate submitted by Somerset Therap LLC.

RegulatoryJuly 12, 2026

FDA Approves KEYTRUDA and KEYTRUDA QLEX for Muscle-Invasive Bladder Cancer

The FDA has approved KEYTRUDA and KEYTRUDA QLEX in combination with Padcev for MIBC treatment before and after surgery.

RegulatoryJuly 12, 2026

FDA Approval Status Update for Deutetrabenazine by Aurobindo Pharma

Aurobindo Pharma's application for deutetrabenazine has been submitted and is under standard review.

RegulatoryJuly 12, 2026

FDA Approval Update for Children's Advil (Ibuprofen) by Haleon

The FDA has accepted a supplemental application for Children's Advil (Ibuprofen) from Haleon.

RegulatoryJuly 12, 2026

FDA Approval for Children's Advil-Flavored Supplement by Haleon

The FDA has approved the NDA for Children's Advil-Flavored Supplement, containing ibuprofen.

StrategyJuly 11, 2026

FDA Approves Pregabalin ANDA219593 by Unichem

The FDA has approved the Abbreviated New Drug Application (ANDA) for Pregabalin submitted by Unichem.

RegulatoryJuly 11, 2026

Lupin's Glycerol Phenylbutyrate Receives FDA Approval Status

The FDA has granted an approval status of 'AP' for Lupin's application ANDA207694 for Glycerol Phenylbutyrate.

RegulatoryJuly 11, 2026

FDA Approves Supplemental Application for PERSERIS Kit by INDIVIOR

The FDA has approved a supplemental application for the PERSERIS Kit, which contains risperidone.

RegulatoryJuly 11, 2026

FDA Approves ANDA for Fluorescein Sodium by BPI Labs

The FDA has approved the ANDA220046 for Fluorescein Sodium submitted by BPI Labs.

StrategyJuly 11, 2026

FDA Approval Update for Omeprazole ANDA207740 by Dr. Reddy's

Reddy's has submitted an Abbreviated New Drug Application (ANDA) for Omeprazole, currently under review.

RegulatoryJuly 11, 2026

FDA Approves Pembrolizumab Combinations for Muscle Invasive Bladder Cancer

The FDA has approved pembrolizumab alone or in combination with berahyaluronidase alfa-pmph and enfortumab vedotin-ejfv for muscle invasive bladder cancer.

RegulatoryJuly 11, 2026

FDA Approves Isatuximab-irfc Subcutaneous Injection for Multiple Myeloma

The FDA has approved isatuximab-irfc for subcutaneous administration in multiple myeloma.

RegulatoryJuly 11, 2026

FDA Approves PADCEV plus Keytruda for Muscle-Invasive Bladder Cancer Treatment

The FDA has approved PADCEV in combination with Keytruda as a neoadjuvant and adjuvant treatment for muscle-invasive bladder cancer, regardless of cisplatin eligibility.

RegulatoryJuly 10, 2026

FDA Approves Supplemental Application for RINVOQ LQ by AbbVie

The FDA has approved a supplemental application for RINVOQ LQ (upadacitinib) submitted by AbbVie.

RegulatoryJuly 10, 2026

FDA Approval Application for Rivaroxaban by Mankind Pharma

Mankind Pharma has submitted an application for Rivaroxaban under ANDA220874, currently under standard review.

RegulatoryJuly 9, 2026

FDA Approval Status Update for Remifentanil Hydrochloride by Fresenius Kabi

Fresenius Kabi USA has submitted a supplemental application for Remifentanil Hydrochloride, currently under standard review.

RegulatoryJuly 9, 2026

FDA Approves Supplemental Application for XELJANZ XR by Pfizer

The FDA has approved a supplemental application for XELJANZ XR, JAK inhibitor developed by Pfizer.

RegulatoryJuly 9, 2026

FDA Approves Supplemental Application for Levothyroxine Sodium by Fresenius Kabi

The FDA has approved a supplemental application for Levothyroxine Sodium submitted by Fresenius Kabi.

RegulatoryJuly 9, 2026

FDA Approval Status for Tranexamic Acid by Micro Labs

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Tranexamic Acid submitted by Micro Labs.

RegulatoryJuly 9, 2026

FDA Approval Letter for Verapamil Hydrochloride ANDA078306

The FDA has issued an approval letter for the ANDA078306 application for Verapamil Hydrochloride.

StrategyJuly 9, 2026

FDA Approves ANDA217934 for Brimonidine Tartrate and Timolol Maleate

The FDA has approved ANDA217934, a generic formulation containing Brimonidine Tartrate and Timolol Maleate.

StrategyJuly 9, 2026

Sandoz Receives FDA Approval for Liraglutide ANDA212972

Sandoz has received an Abbreviated New Drug Application (ANDA) approval for Liraglutide.

RegulatoryJuly 8, 2026

FDA Approves Supplemental NDA for Pfizer's Ritlecitinib Tosylate (Litfulo)

The FDA has approved a supplemental NDA for Litfulo (ritlecitinib tosylate) submitted by Pfizer.

RegulatoryJuly 8, 2026

FDA Approves Supplemental Application for TRUXIMA (Rituximab-ABBS)

The FDA has approved a supplemental application for TRUXIMA, a biosimilar to Rituximab, developed by Celltrion.

RegulatoryJuly 8, 2026

FDA Approves Supplemental NDA for HEPZATO by Delcath Systems

The FDA has approved a supplemental NDA for HEPZATO, which contains melphalan hydrochloride.

RegulatoryJuly 8, 2026

FDA Approves Supplemental Application for Strattera by Lilly

The FDA has approved a supplemental application for Strattera (atomoxetine hydrochloride) submitted by Lilly.

RegulatoryJuly 8, 2026

FDA Approves Supplemental Application for TASCENSO ODT

The FDA has approved a supplemental application for TASCENSO ODT, containing Fingolimod Lauryl Sulfate.

RegulatoryJuly 8, 2026

FDA Approves Trutakna for Proteinuria in Primary IgA Nephropathy

The FDA has approved Trutakna (atacicept-vymj) for reducing proteinuria in adults with primary IgA nephropathy.

RegulatoryJuly 8, 2026

FDA Approves Supplemental Application for CRESTOR (Rosuvastatin Calcium)

The FDA has approved a supplemental application for CRESTOR, a statin medication.

StrategyJuly 8, 2026

UMEDICA LABS Receives FDA Approval for OXCARBAZEPINE ANDA218341

UMEDICA LABS has received FDA approval for their Abbreviated New Drug Application (ANDA) for OXCARBAZEPINE.

RegulatoryJuly 7, 2026

FDA Approves Veklury as First Treatment for COVID-19

The FDA has approved Veklury (remdesivir) as the first treatment for COVID-19 in hospitalized patients.

StrategyJuly 7, 2026

FDA Approves ANDA for Pomalidomide by Hetero Labs

The FDA has approved ANDA210236 for pomalidomide submitted by Hetero Labs.

RegulatoryJuly 6, 2026

FDA Approves Supplemental Application for Breztri Aerosphere

The FDA has approved a supplemental application for Breztri Aerosphere, containing budesonide, formoterol fumarate, and glycopyrrolate.

RegulatoryJuly 6, 2026

FDA Approves Supplemental Application for Thalidomide (Thalomid)

The FDA has approved a supplemental application for Thalomid (thalidomide) submitted by Bristol-Myers.

StrategyJuly 5, 2026

Teva's Budesonide and Formoterol Fumarate Dihydrate Receives FDA Approval

Teva Pharmaceuticals has received FDA approval for ANDA212212, a generic formulation of Budesonide and Formoterol Fumarate Dihydrate.

StrategyJuly 5, 2026

FDA Approves ANDA204687 for Valsartan and Hydrochlorothiazide

The FDA has approved ANDA204687, a generic formulation of Valsartan and Hydrochlorothiazide, submitted by Sciegen Pharmaceuticals.

StrategyJuly 5, 2026

FDA Approves ANDA for Escitalopram Oxalate by Micro Labs

The FDA has granted approval for ANDA091655, a generic version of Escitalopram Oxalate submitted by Micro Labs.

StrategyJuly 5, 2026

FDA Approves ANDA078324 for Estradiol and Norethindrone Acetate

The FDA has granted approval for ANDA078324, a generic formulation of estradiol and norethindrone acetate.

StrategyJuly 5, 2026

Sandoz Receives FDA Approval for Enzalutamide ANDA216068

Sandoz has received FDA approval for its Abbreviated New Drug Application (ANDA) for Enzalutamide.

RegulatoryJuly 4, 2026

FDA Approves Supplemental Application for Cosentyx (Secukinumab)

The FDA has approved a supplemental application for Cosentyx (Secukinumab) submitted by Novartis.

RegulatoryJuly 4, 2026

FDA Approves Lamotrigine Supplement from Glenmark Pharmaceuticals

The FDA has approved a supplement for Lamotrigine submitted by Glenmark Pharmaceuticals.

RegulatoryJuly 4, 2026

FDA Approval Update for Buprenorphine and Naloxone from Dr. Reddy's Labs

The FDA has accepted the supplemental application ANDA205806 for Buprenorphine Hydrochloride and Naloxone Hydrochloride from Dr. Reddy's Labs.

RegulatoryJuly 3, 2026

FDA Approval Status Update for Bosentan ANDA207760 by Zydus Pharmaceuticals

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Bosentan submitted by Zydus Pharmaceuticals.

RegulatoryJuly 3, 2026

FDA Approves Supplemental Application for SARCLISA (Isatuximab-IRFC)

The FDA has approved a supplemental application for SARCLISA, a monoclonal antibody targeting CD38.

RegulatoryJuly 3, 2026

FDA Approves Supplemental Applications for TRELSTAR

The FDA has approved supplemental applications for TRELSTAR, a triptorelin pamoate product.

RegulatoryJuly 3, 2026

FDA Approves BLA761530 (LUMVOA) from Viridian Therapeutics

The FDA has approved BLA761530, known as LUMVOA, submitted by Viridian Therapeutics.

CompetitiveJuly 3, 2026

FDA Approves Lamotrigine Supplement from Alembic Pharmaceuticals

The FDA has approved a supplemental application for Lamotrigine submitted by Alembic Pharmaceuticals.

RegulatoryJuly 2, 2026

FDA Approves Casgevy for Young Children with Sickle Cell Disease

The FDA has granted supplemental approval for Casgevy for young children with sickle cell disease and transfusion-dependent β thalassemia.

RegulatoryJuly 1, 2026

FDA Approval for Children's Advil-Flavored Supplement by Haleon

The FDA has approved the supplemental application for Children's Advil-Flavored, containing ibuprofen.

RegulatoryJuly 1, 2026

FDA Approves Ferric Carboxymaltose ANDA212572 by Mylan Labs

The FDA has approved the Abbreviated New Drug Application (ANDA) for Ferric Carboxymaltose submitted by Mylan Labs.

RegulatoryJuly 1, 2026

FDA Approves Supplement for Bicillin L-A by King Pharmaceuticals

The FDA has granted approval for a supplemental application for Bicillin L-A, containing Penicillin G Benzathine.

StrategyJuly 1, 2026

FDA Approves Dapsone ANDA213414 by Alembic

The FDA has approved ANDA213414 for Dapsone submitted by Alembic.

StrategyJuly 1, 2026

FDA Approves ANDA217769 for Ferric Carboxymaltose by Mylan

The FDA has granted approval for the Abbreviated New Drug Application ANDA217769 for Ferric Carboxymaltose submitted by Mylan.

RegulatoryJuly 1, 2026

FDA Approves Fluocinolone Acetonide Supplement by Sun Pharma

The FDA has approved a supplemental application for Fluocinolone Acetonide submitted by Sun Pharma.

RegulatoryJuly 1, 2026

FDA Approves Allogeneic T Cell Immunotherapy for Hematologic Malignancies

The FDA has approved a new allogeneic regulatory T cell-based immunotherapy for use in matched donor hematopoietic stem cell transplantation.

RegulatoryJuly 1, 2026

FDA Approves TREGZI for Chronic GVHD in Blood Cancer Patients

The FDA has approved TREGZI, the first Treg cell-based immunotherapy for chronic GVHD-free survival in blood cancer patients.

RegulatoryJune 30, 2026

FDA Approval Update for IBRANCE (Palbociclib) by Pfizer

The FDA has accepted the supplemental application for IBRANCE (palbociclib) from Pfizer.

RegulatoryJune 30, 2026

FDA Approves Supplement for KEYTRUDA (pembrolizumab) by Merck

The FDA has approved a supplemental application for KEYTRUDA (pembrolizumab) from Merck.

RegulatoryJune 30, 2026

FDA Approves Supplemental Application for AJOVY (Fremanezumab)

The FDA has approved a supplemental application for AJOVY, a migraine treatment by Teva Pharmaceuticals.

RegulatoryJune 30, 2026

FDA Approves Supplemental Application for Epidiolex by Jazz Pharmaceuticals

The FDA has approved a supplemental application for Epidiolex, which contains cannabidiol as its active ingredient.

RegulatoryJune 30, 2026

FDA Approves Supplemental Application for Children's Allegra Hives

The FDA has approved a supplemental application for Children's Allegra Hives, containing fexofenadine hydrochloride.

RegulatoryJune 30, 2026

FDA Approves Tioprinin for Treatment of Cystinosis

The FDA has approved Tioprinin under NDA212927 for the treatment of cystinosis.

RegulatoryJune 29, 2026

FDA Approval for Oxycodone Hydrochloride Supplement by Sun Pharma

The FDA has approved a supplement for Oxycodone Hydrochloride submitted by Sun Pharma.

RegulatoryJune 29, 2026

FDA Approval Status for Methadone Hydrochloride by ThePharmaNetwork LLC

The FDA has granted approval status (AP) for Methadone Hydrochloride under application ANDA090635 submitted by ThePharmaNetwork LLC.

RegulatoryJune 29, 2026

FDA Approval Status Update for Tramadol Hydrochloride and Acetaminophen

The FDA has provided an approval status update for the ANDA201952 application for Tramadol Hydrochloride and Acetaminophen submitted by Micro Labs Ltd India.

RegulatoryJune 29, 2026

FDA Approves Morphine Sulfate Supplement by Actavis Elizabeth

The FDA has approved a supplement for Morphine Sulfate submitted by Actavis Elizabeth.

RegulatoryJune 29, 2026

FDA Approval Letter for Tramadol Hydrochloride by Sun Pharma

The FDA has issued an approval letter for the ANDA076100 application for Tramadol Hydrochloride submitted by Sun Pharma.

RegulatoryJune 29, 2026

FDA Approves Supplemental NDA for NUCYNTA (Tapentadol Hydrochloride)

The FDA has approved a supplemental NDA for NUCYNTA, indicating a new development in its regulatory status.

RegulatoryJune 29, 2026

FDA Approves Supplemental Application for Methadone Hydrochloride Intensol by Hikma

The FDA has approved a supplemental application for Methadone Hydrochloride Intensol submitted by Hikma.

RegulatoryJune 29, 2026

FDA Approves Supplement for Butalbital, Aspirin, Caffeine, and Codeine Phosphate

The FDA has approved a supplemental application for a combination product containing butalbital, aspirin, caffeine, and codeine phosphate.

RegulatoryJune 29, 2026

FDA Approval for Oxycodone Hydrochloride Supplement by Actavis Elizabeth

The FDA has approved a supplement application for Oxycodone Hydrochloride submitted by Actavis Elizabeth.

RegulatoryJune 29, 2026

FDA Approval Update for Hydrocodone Bitartrate and Ibuprofen by Amneal Pharmaceuticals

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for a combination of hydrocodone bitartrate and ibuprofen by Amneal Pharmaceuticals.

RegulatoryJune 29, 2026

FDA Approval Status Update for Hydromorphone Hydrochloride by Hikma

The FDA has issued an approval status update for Hikma's ANDA074597 for Hydromorphone Hydrochloride.

StrategyJune 29, 2026

FDA Approval of Oxycodone Hydrochloride ANDA203823 by Lannett Co Inc

The FDA has approved the Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride submitted by Lannett Co Inc.

RegulatoryJune 29, 2026

FDA Approval of Oxymorphone Hydrochloride Supplement by Actavis Elizabeth

The FDA has approved a supplemental application for Oxymorphone Hydrochloride submitted by Actavis Elizabeth.

RegulatoryJune 28, 2026

FDA Approval Status Update for PERCOCET (ANDA040330)

The FDA has updated the submission status for PERCOCET under ANDA040330 to Approved (AP) with a supplemental application.

RegulatoryJune 28, 2026

FDA Approval Letter for Oxycodone and Acetaminophen Supplement

The FDA has issued an approval letter for the supplement application of Oxycodone and Acetaminophen by Rhodes Pharmaceuticals.

RegulatoryJune 28, 2026

FDA Approval Update for Oxycodone and Acetaminophen by Lannett Co Inc

Lannett Co Inc has received an approval status for their ANDA submission for Oxycodone and Acetaminophen.

RegulatoryJune 28, 2026

FDA Approval for Morphine Sulfate Supplement by Actavis Elizabeth

The FDA has approved a supplement application for Morphine Sulfate submitted by Actavis Elizabeth.

RegulatoryJune 28, 2026

FDA Approval for Tramadol Hydrochloride and Acetaminophen Combination

The FDA has approved the ANDA077858 application for a combination of Tramadol Hydrochloride and Acetaminophen.

RegulatoryJune 28, 2026

FDA Approval Letter for Oxycodone Hydrochloride ANDA204979

The FDA has issued an approval letter for Oxycodone Hydrochloride under ANDA204979 submitted by ANI Pharmaceuticals.

RegulatoryJune 28, 2026

FDA Approval Update for Hydrocodone Bitartrate and Acetaminophen by Strides Pharma

The FDA has granted an approval status (AP) for the ANDA040355 application for Hydrocodone Bitartrate and Acetaminophen submitted by Strides Pharma.

RegulatoryJune 28, 2026

FDA Approval for Morphine Sulfate Supplement by Strides Pharma

The FDA has approved a supplemental application for Morphine Sulfate submitted by Strides Pharma.

RegulatoryJune 28, 2026

FDA Approves Supplemental Application for Methadone Hydrochloride by Vistapharm

The FDA has approved a supplemental application for Methadone Hydrochloride submitted by Vistapharm LLC.

RegulatoryJune 28, 2026

FDA Approval Status Update for Hydrocodone Bitartrate by Alvogen

The FDA has issued an approval status update for Alvogen's ANDA206986 for Hydrocodone Bitartrate.

RegulatoryJune 28, 2026

FDA Approval Status for Acetaminophen and Codeine Phosphate (ANDA211610)

The FDA has granted an approval status of 'AP' for ANDA211610, a combination of acetaminophen and codeine phosphate.

RegulatoryJune 28, 2026

FDA Approval Status Update for Hydromorphone Hydrochloride Supplement

The FDA has granted an approval status of AP for the hydromorphone hydrochloride supplement submitted by Padagis US.

RegulatoryJune 28, 2026

FDA Approval of Hydrocodone Bitartrate and Acetaminophen Supplement

The FDA has approved a supplemental application for Hydrocodone Bitartrate and Acetaminophen under ANDA205001 by Strides Pharma Intl.

RegulatoryJune 28, 2026

FDA Approval Update for Tramadol Hydrochloride Supplement by Strides Pharma

Strides Pharma International has received an approval status for the supplemental application of Tramadol Hydrochloride.

RegulatoryJune 28, 2026

FDA Approval for Morphine Sulfate Supplement by Tris Pharma

The FDA has approved a supplemental application for Morphine Sulfate submitted by Tris Pharma.

StrategyJune 28, 2026

FDA Approval Letter for Morphine Sulfate by Upsher Smith Labs

The FDA has issued an approval letter for ANDA210610, indicating that Upsher Smith Labs' morphine sulfate product meets regulatory requirements.

RegulatoryJune 28, 2026

FDA Approval Update for Acetaminophen and Codeine Phosphate by Pharmobedient

The FDA has issued an approval letter for ANDA087006 concerning Acetaminophen and Codeine Phosphate.

RegulatoryJune 28, 2026

FDA Approves Supplemental NDA for OXAYDO by ZYLA

The FDA has approved a supplemental NDA for OXAYDO, an oxycodone hydrochloride product.

StrategyJune 28, 2026

FDA Approval Update for Hydrocodone Bitartrate and Acetaminophen by SPECGX LLC

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for Hydrocodone Bitartrate and Acetaminophen submitted by SPECGX LLC.

RegulatoryJune 28, 2026

FDA Approves Supplement for NUCYNTA (Tapentadol Hydrochloride)

The FDA has approved a supplemental application for NUCYNTA, indicating potential new uses or formulations.

RegulatoryJune 28, 2026

FDA Approval for ANEXSIA 7.5/325 by SPECGX LLC

The FDA has granted approval for ANEXSIA 7.5/325, a combination of acetaminophen and hydrocodone bitartrate.

StrategyJune 28, 2026

FDA Approves ANEXSIA 5/325 Submission by SPECGX LLC

The FDA has approved the ANDA submission for ANEXSIA 5/325, containing acetaminophen and hydrocodone bitartrate.

RegulatoryJune 28, 2026

FDA Approves Supplemental Application for Oxycodone and Acetaminophen

The FDA has approved a supplemental application for a combination product containing oxycodone hydrochloride and acetaminophen.

RegulatoryJune 28, 2026

FDA Approval Status Update for Acetaminophen and Codeine Phosphate

The FDA has granted an AP status for the ANDA040419 application submitted by SPECGX LLC for Acetaminophen and Codeine Phosphate.

RegulatoryJune 27, 2026

FDA Approval Update for Oxycodone Hydrochloride and Acetaminophen

The FDA has issued an approval letter for ANDA203573, a combination of oxycodone hydrochloride and acetaminophen.

RegulatoryJune 27, 2026

FDA Approves Supplement for Morphine Sulfate by ANI Pharmaceuticals

ANI Pharmaceuticals received FDA approval for a supplement related to Morphine Sulfate.

RegulatoryJune 27, 2026

FDA Approval for Oxycodone Hydrochloride Supplement by ABHAI LLC

The FDA has approved a supplemental application for Oxycodone Hydrochloride submitted by ABHAI LLC.

StrategyJune 27, 2026

FDA Approval Letter for Tramadol Hydrochloride by Sun Pharma

The FDA has issued an approval letter for the ANDA075964 application for Tramadol Hydrochloride submitted by Sun Pharmaceutical Industries.

RegulatoryJune 27, 2026

FDA Approves Supplemental Application for Trodelvy (Sacituzumab Govitecan-Hziy)

The FDA has approved a supplemental application for Trodelvy, a drug developed by Immunomedics Inc.

RegulatoryJune 27, 2026

FDA Approves Supplemental Application for IBRANCE (Palbociclib)

The FDA has approved a supplemental application for IBRANCE, CDK4/6 inhibitor developed by Pfizer.

RegulatoryJune 27, 2026

FDA Approves ANDA220768 for Fluvoxamine Maleate by Micro Labs

The FDA has approved the Abbreviated New Drug Application (ANDA220768) for Fluvoxamine Maleate submitted by Micro Labs.

RegulatoryJune 27, 2026

FDA Approves ANDA for Bupropion Hydrochloride by Macleods

The FDA has approved ANDA218567 for Bupropion Hydrochloride submitted by Macleods Pharmaceuticals.

RegulatoryJune 27, 2026

FDA Approves KEYTRUDA and Trodelvy Combination for First-Line TNBC Treatment

The FDA has approved KEYTRUDA and KEYTRUDA QLEX in combination with Trodelvy for first-line treatment of PD-L1+ advanced TNBC.

RegulatoryJune 27, 2026

FDA Approves Supplemental Application for Copaxone (Glatiramer Acetate)

The FDA has approved a supplemental application for Copaxone, a treatment for multiple sclerosis.

RegulatoryJune 27, 2026

FDA Approves Supplemental Application for Butrans by KNOA Pharma

The FDA has approved a supplemental application for Butrans, which contains buprenorphine as the active ingredient.

RegulatoryJune 26, 2026

FDA Approval Update for FIORICET with Codeine Supplement

The FDA has accepted a supplemental application for FIORICET with Codeine from Actavis Labs.

RegulatoryJune 26, 2026

FDA Approves Supplemental Application for Dilaudid by Rhodes Pharmaceuticals

The FDA has approved a supplemental application for Dilaudid, containing hydromorphone hydrochloride.

RegulatoryJune 26, 2026

FDA Approves Supplemental NDA for QDOLO (Tramadol Hydrochloride)

The FDA has approved a supplemental NDA for QDOLO, which contains tramadol hydrochloride.

RegulatoryJune 26, 2026

FDA Approval Update for Morphine Sulfate by Hikma

The FDA has issued an approval letter for the supplemental application of Morphine Sulfate by Hikma.

RegulatoryJune 26, 2026

FDA Approves Supplement for XTAMPZA ER by Collegium Pharma

The FDA has approved a supplemental application for XTAMPZA ER, an extended-release formulation of oxycodone.

RegulatoryJune 26, 2026

FDA Approves Supplemental Application for OXAYDO by ZYLA

The FDA has approved a supplemental application for OXAYDO, an oxycodone hydrochloride product.

RegulatoryJune 26, 2026

FDA Approval of Morphine Sulfate Supplement by Novel Labs

The FDA has approved a supplemental application for Morphine Sulfate submitted by Novel Labs Inc.

RegulatoryJune 26, 2026

FDA Approval Update for Tramadol Hydrochloride by Graviti Pharms

The FDA has updated the application status for Tramadol Hydrochloride submitted by Graviti Pharms to AP.

RegulatoryJune 26, 2026

FDA Approval for Hydromorphone Hydrochloride Supplement by Actavis Labs

The FDA has approved a supplemental application for Hydromorphone Hydrochloride submitted by Actavis Labs.

RegulatoryJune 26, 2026

FDA Approves Supplement for Morphine Sulfate by Rhodes Pharmaceuticals

The FDA has approved a supplemental application for Morphine Sulfate submitted by Rhodes Pharmaceuticals.

RegulatoryJune 26, 2026

FDA Approval Status Update for Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate

The FDA has provided an approval status update for ANDA204209, a combination product containing acetaminophen, caffeine, and dihydrocodeine bitartrate.

RegulatoryJune 26, 2026

FDA Approves Supplemental Application for CONZIP (Tramadol Hydrochloride)

The FDA has approved a supplemental application for CONZIP, which contains tramadol hydrochloride.

RegulatoryJune 26, 2026

FDA Approval Status for Morphine Sulfate ANDA200812 by Strides Pharma

The FDA has granted approval status (AP) for ANDA200812, a morphine sulfate product from Strides Pharma.

RegulatoryJune 26, 2026

FDA Approves Supplemental NDA for SYNALGOS-DC by Sun Pharma

The FDA has approved a supplemental NDA for SYNALGOS-DC, which contains aspirin, caffeine, and dihydrocodeine bitartrate.

StrategyJune 25, 2026

FDA Approves ANDA for Oxymorphone Hydrochloride by Hikma

The FDA has approved the ANDA for Oxymorphone Hydrochloride submitted by Hikma.

RegulatoryJune 25, 2026

FDA Approval Update for Teva's Tramadol Hydrochloride Supplement

Teva's supplemental application for Tramadol Hydrochloride has received an approval status from the FDA.

RegulatoryJune 25, 2026

FDA Approval Update for Tramadol Hydrochloride by SPECGX LLC

The FDA has granted an approval status for the ANDA075983 application concerning Tramadol Hydrochloride.

RegulatoryJune 25, 2026

FDA Approves Oxycodone Hydrochloride Supplement by Rhodes Pharmaceuticals

The FDA has approved a supplemental application for Oxycodone Hydrochloride submitted by Rhodes Pharmaceuticals.

StrategyJune 25, 2026

FDA Approval Letter for Hydrocodone Bitartrate and Acetaminophen

The FDA has issued an approval letter for ANDA207137, a combination of hydrocodone bitartrate and acetaminophen.

RegulatoryJune 25, 2026

FDA approves sacituzumab govitecan-hziy for first-line triple-negative breast cancer

The FDA has approved sacituzumab govitecan-hziy both as a monotherapy and in combination with pembrolizumab for the first-line treatment of triple-negative breast cancer.

RegulatoryJune 25, 2026

FDA Approves Tryngolza for Reducing Acute Pancreatitis Risk in Severe Hypertriglyceridemia

The FDA has approved Tryngolza (olezarsen) for reducing triglycerides and the risk of acute pancreatitis in adults.

RegulatoryJune 25, 2026

FDA Approves Palbociclib with Trastuzumab for HR-positive, HER2-positive Breast Cancer

The FDA has approved palbociclib in combination with trastuzumab, with or without pertuzumab, for maintenance treatment in HR-positive, HER2-positive metastatic breast cancer.

RegulatoryJune 25, 2026

FDA Approves Pfizer’s IBRANCE for HR+, HER2+ Metastatic Breast Cancer Maintenance

The FDA has approved IBRANCE in combination with trastuzumab and endocrine therapy for HR+, HER2+ metastatic breast cancer maintenance treatment, based on the Phase 3 PATINA trial results.

RegulatoryJune 25, 2026

FDA Approval for Oxycodone Hydrochloride by Novel Labs

The FDA has granted approval for ANDA204021, a supplemental application for Oxycodone Hydrochloride by Novel Labs.

RegulatoryJune 25, 2026

FDA Approval for Amneal's Tramadol Hydrochloride Supplement

The FDA has granted approval for Amneal Pharmaceuticals' supplemental application for Tramadol Hydrochloride.

RegulatoryJune 25, 2026

FDA Approves Supplement for Morphine Sulfate by Alkem Labs

The FDA has approved a supplemental application for Morphine Sulfate submitted by Alkem Labs.

RegulatoryJune 25, 2026

FDA Approves Oxycodone Hydrochloride Supplement by Strides Pharma

The FDA has approved a supplemental application for Oxycodone Hydrochloride submitted by Strides Pharma.

RegulatoryJune 24, 2026

FDA Approval Update for Oxycodone and Acetaminophen Supplement

The FDA has issued an approval letter for the supplement application of Oxycodone and Acetaminophen submitted by Actavis Elizabeth.

RegulatoryJune 24, 2026

FDA Approval for Methadone Hydrochloride by Sun Pharma

The FDA has approved the supplemental application ANDA208305 for Methadone Hydrochloride submitted by Sun Pharma.

RegulatoryJune 24, 2026

FDA Approval Status Update for Hydromorphone Hydrochloride by Osmotica

The FDA has issued an approval status update for ANDA205629 concerning Hydromorphone Hydrochloride.

RegulatoryJune 24, 2026

FDA Approves Supplement for Methadone Hydrochloride by Hikma

The FDA has approved a supplemental application for Methadone Hydrochloride submitted by Hikma.

RegulatoryJune 24, 2026

FDA Approves Supplemental Application for Methadone Hydrochloride by Vistapharm

The FDA has approved a supplemental application for Methadone Hydrochloride submitted by Vistapharm LLC.

StrategyJune 24, 2026

FDA Approves First Generic of Priftin (rifapentine) Tablets

The FDA has approved the first generic version of Priftin (rifapentine) tablets for treating active pulmonary tuberculosis.

RegulatoryJune 24, 2026

FDA Approval Letter for Oxycodone and Aspirin Combination

The FDA has issued an approval letter for ANDA040260 concerning a combination of oxycodone and aspirin.

RegulatoryJune 24, 2026

FDA Approval Status Update for Oxycodone Hydrochloride by Pharmobedient

The FDA has provided an approval status update for ANDA206456, a supplemental application for Oxycodone Hydrochloride submitted by Pharmobedient.

StrategyJune 24, 2026

FDA Approval Letter for Hydrocodone Bitartrate and Acetaminophen

The FDA has issued an approval letter for ANDA206869, a combination of hydrocodone bitartrate and acetaminophen.

RegulatoryJune 24, 2026

FDA Approval for Tramadol Hydrochloride Supplement by Sun Pharma

The FDA has approved a supplement application for Tramadol Hydrochloride submitted by Sun Pharma.

RegulatoryJune 23, 2026

FDA Approves Supplemental Application for Epcoritamab (EPKINLY)

The FDA has approved a supplemental application for Epcoritamab (EPKINLY) submitted by Genmab US, Inc.

StrategyJune 23, 2026

FDA Approves Solriamfetol Hydrochloride by Alkem Labs

The FDA has approved Solriamfetol Hydrochloride under application ANDA218722 submitted by Alkem Labs.

RegulatoryJune 23, 2026

FDA Approves Baloxavir Marboxil for ANDA217449

The FDA has approved Baloxavir Marboxil under ANDA217449 submitted by Norwich.

RegulatoryJune 23, 2026

FDA Approval Status Update for Isotretinoin by Upsher Smith Labs

The FDA has granted an Approval Pending (AP) status for the isotretinoin application ANDA213571 submitted by Upsher Smith Labs.

RegulatoryJune 23, 2026

FDA Approves Bosutinib Monohydrate for Market

The FDA has approved the application ANDA209624 for Bosutinib Monohydrate submitted by MSN.

StrategyJune 22, 2026

FDA Approves ANDA for Tofacitinib Citrate by MSN

The FDA has approved the ANDA217299 application for Tofacitinib Citrate submitted by MSN.

RegulatoryJune 22, 2026

FDA Approval Status for Cyclobenzaprine Hydrochloride Supplement

The FDA has issued an approval status for the supplement application ANDA072854 for Cyclobenzaprine Hydrochloride.

RegulatoryJune 22, 2026

FDA Approves Tzield for Pediatric Stage 3 Type I Diabetes

The FDA has approved Tzield (teplizumab) for delaying insulin loss in pediatric patients with Stage 3 Type I diabetes.

RegulatoryJune 22, 2026

FDA Approves First OTC Continuous Glucose Monitor for Children

The FDA has cleared Dexcom Inc.'s Stelo Glucose Biosensor System as the first OTC continuous glucose monitor for children aged two and older.

RegulatoryJune 22, 2026

FDA approves capivasertib with abiraterone for PTEN-deficient prostate cancer

Capivasertib has been approved by the FDA for use with abiraterone and prednisone in treating PTEN-deficient metastatic prostate cancer.

RegulatoryJune 22, 2026

FDA approves belzutifan with pembrolizumab for renal cell carcinoma treatment

The FDA has approved belzutifan in combination with pembrolizumab for the adjuvant treatment of renal cell carcinoma.

RegulatoryJune 21, 2026

FDA Approves Supplement for Fluorescite by Alcon Labs

The FDA has approved a supplemental application for Fluorescite, which contains fluorescein sodium.

StrategyJune 21, 2026

FDA Approves ANDA for Valacyclovir Hydrochloride by Hetero Labs

The FDA has approved ANDA203047 for Valacyclovir Hydrochloride submitted by Hetero Labs.

StrategyJune 21, 2026

Aurobindo Pharma's Cephalexin Receives FDA Approval

Aurobindo Pharma's ANDA213568 for Cephalexin has received FDA approval.

RegulatoryJune 21, 2026

FDA Approves Supplemental Application for Capecitabine by Accord Healthcare

The FDA has approved a supplemental application for Capecitabine submitted by Accord Healthcare.

StrategyJune 21, 2026

FDA Approves ANDA for Tofacitinib Citrate by Auson

The FDA has approved the ANDA219370 for Tofacitinib Citrate submitted by Auson.

RegulatoryJune 21, 2026

FDA Approves Linezolid in Sodium Chloride 0.9% for Hospira

The FDA has approved Linezolid in Sodium Chloride 0.9% in a plastic container under NDA206473.

RegulatoryJune 21, 2026

FDA Approves Supplemental Applications for ZYVOX by Pfizer

The FDA has approved supplemental applications for ZYVOX (linezolid), indicating ongoing support for this antibiotic.

RegulatoryJune 21, 2026

FDA Approves Supplement for Vancomycin Hydrochloride in Plastic Container

The FDA has approved a supplemental application for Vancomycin Hydrochloride in a plastic container by Baxter Healthcare.

RegulatoryJune 21, 2026

FDA Approves Supplement for Estradiol by Mylan Technologies

The FDA has approved a supplemental application for estradiol submitted by Mylan Technologies.

StrategyJune 20, 2026

FDA Approves Albuterol Sulfate ANDA219409 from Cipla

The FDA has approved ANDA219409 for Albuterol Sulfate submitted by Cipla.

RegulatoryJune 20, 2026

FDA Approves OTC Naloxone Nasal Spray Rextovy for Opioid Overdose

The FDA has approved Rextovy, a 4 mg naloxone nasal spray, for over-the-counter use in treating opioid overdose.

StrategyJune 19, 2026

FDA Approves Hydroxyzine Hydrochloride ANDA220271 by Saptalis Pharmaceuticals

The FDA has approved ANDA220271 for Hydroxyzine Hydrochloride submitted by Saptalis Pharmaceuticals.

StrategyJune 19, 2026

FDA Approves ANDA216272 for Norepinephrine Bitartrate by Nephron

The FDA has approved ANDA216272, a generic formulation of Norepinephrine Bitartrate, submitted by Nephron.

StrategyJune 19, 2026

FDA Approves First Generic of Xofluza for Influenza Treatment

The FDA has approved the first generic version of Xofluza, a single-dose treatment for influenza.

RegulatoryJune 19, 2026

FDA Approves First Oral Carbapenem for Complicated UTIs

The FDA has approved the first oral carbapenem therapy specifically for complicated urinary tract infections.

RegulatoryJune 19, 2026

FDA Approves CAPVAXIVE for At-Risk Children and Adolescents

The FDA has approved an expanded indication for CAPVAXIVE to include children and adolescents aged 2-17 at increased risk for pneumococcal disease.

RegulatoryJune 18, 2026

FDA Approves Supplemental Application for REXTOVY by Amphastar Pharmaceuticals

The FDA has approved a supplemental application for REXTOVY, containing naloxone hydrochloride.

StrategyJune 18, 2026

FDA Approval Update for Divalproex Sodium by Mylan

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for Divalproex Sodium submitted by Mylan.

RegulatoryJune 18, 2026

FDA Approves Supplemental Application for Zyrtec Hives by Kenvue Brands

The FDA has approved a supplemental application for Zyrtec Hives, containing cetirizine hydrochloride.

RegulatoryJune 17, 2026

FDA Approves Supplement for INQOVI (NDA 212576) by Taiho Oncology

The FDA has approved a supplemental application for INQOVI, which contains the active ingredients cedazuridine and decitabine.

RegulatoryJune 17, 2026

FDA Approves Merck’s IDVYNSO for Virologically Suppressed HIV-1 Patients

Merck's IDVYNSO, a two-drug regimen, has been approved by the FDA for adults with virologically suppressed HIV-1.

CompetitiveJune 17, 2026

Overview of Antibody-Drug Conjugates in Cancer Therapy and Clinical Development

Antibody-drug conjugates (ADCs) have shown significant clinical benefits in advanced phase trials for various cancers, with over a dozen receiving FDA approval.

RegulatoryJune 17, 2026

Merck Receives FDA Approval for IDVYNSO, Expands Oncology Pipeline and Animal Health Sales

Merck has received U.S. FDA approval for IDVYNSO, a once-daily oral treatment for certain adults with virologically suppressed HIV-1.

RegulatoryJune 16, 2026

FDA Approves Bizengri for NRG1 Fusion-Positive Cholangiocarcinoma

The FDA has approved Bizengri (zenocutuzumab-zbco) for the treatment of NRG1 fusion-positive cholangiocarcinoma.

RegulatoryJune 16, 2026

FDA Approves Tzield for Pediatric Patients with Stage 3 Type 1 Diabetes

The FDA granted accelerated approval for Tzield (teplizumab) to delay insulin production decline in pediatric patients with Stage 3 T1D.

RegulatoryJune 16, 2026

FDA approves Lilly's EBGLYSS® for atopic dermatitis with unique dosing regimen

Lilly's EBGLYSS® (lebrikizumab-lbkz) is now approved for a maintenance dose every eight weeks, requiring only six injections per year.

RegulatoryJune 16, 2026

Saphnelo Self-Administration Approved in the US for SLE Treatment

AstraZeneca's Saphnelo has received FDA approval for self-administration via a new autoinjector, enhancing patient convenience.

RegulatoryJune 16, 2026

Enhertu Gains FDA Approval for Two New HER2+ Early Breast Cancer Indications

Enhertu has received FDA approval for two new indications in HER2-positive early breast cancer, both before and after surgery.

RegulatoryJune 13, 2026

FDA Approves KEYTRUDA Combinations for Adjuvant Treatment in Clear Cell RCC

The FDA has approved KEYTRUDA and KEYTRUDA QLEX in combination with WELIREG for adjuvant treatment in ccRCC patients, marking a significant advancement in therapy.

RegulatoryJune 13, 2026

Roche's VENTANA PTEN Assay Receives FDA Approval for Prostate Cancer Companion Diagnostic

Roche's VENTANA PTEN (SP218) RxDx Assay is the first FDA-approved companion diagnostic for assessing PTEN protein loss in prostate cancer.

RegulatoryJune 10, 2026

FDA Approves Pfizer’s HYMPAVZI for Expanded Hemophilia A and B Indications

The FDA has approved an expanded indication for Pfizer’s HYMPAVZI to treat hemophilia A or B in patients aged 6 and older, including those with inhibitors.

RegulatoryJune 9, 2026

FDA Approval Status Update for Lidocaine Hydrochloride 0.4% in Dextrose 5%

The FDA has granted an approval status (AP) for ANDA083158, a supplemental application for Lidocaine Hydrochloride 0.4% in Dextrose 5% submitted by Hospira.

RegulatoryJune 8, 2026