Regulatory Event

FDA Approval

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

Recent events: 162
Catalysts: 27
Companies: 54

Recent events(162)

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

Cipla's ANDA214209 for Sumatriptan Receives Abbreviated Approval from FDA

Cipla has received Abbreviated Approval (AP) from the FDA for its ANDA214209 application for Sumatriptan.

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

FDA Approval Process Update for Mycophenolate Mofetil by Strides Pharma

The FDA has an active application (ANDA212634) for Mycophenolate Mofetil submitted by Strides Pharma, currently under standard review.

RegulatoryJune 8, 2026

FDA Approves Supplement for Methylprednisolone Acetate by Sandoz

The FDA has approved a supplemental application for Methylprednisolone Acetate submitted by Sandoz.

RegulatoryJune 7, 2026

FDA Approval Status Update for Losartan Potassium by Micro Labs

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

RegulatoryJune 6, 2026

FDA Approves Deflazacort Supplement Application by Upsher Smith Labs

The FDA has approved a supplemental application for Deflazacort submitted by Upsher Smith Labs.

RegulatoryJune 6, 2026

FDA Approves Supplement for Levetiracetam by Chartwell RX

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

Historical activity(27)

FDA Approval

Ionis Pharmaceuticals — Donidalorsen

Approval would validate Ionis RNA platform in prophylactic rare disease setting.

August 20, 2026 · NDA/BLA

FDA Approval

Biogen — Leqembi

Subcutaneous formulation approval could expand addressable patient pool and access.

August 1, 2026 · NDA/BLA

Topline Data

— B BRAUN

Monitor for the final approval decision and any subsequent market launch timelines.

July 5, 2026 · N/A

Topline Data

— Regulatory Approval

Monitor for the final approval decision and any subsequent market entry timelines for Mylan's Zoledronic Acid.

July 4, 2026 · N/A

Topline Data

Teva — Argatroban

Monitor for the final approval decision and any subsequent market launch timelines.

July 3, 2026 · N/A

Topline Data

AstraZeneca — Datroway

Monitor the final approval decision by the European Commission and subsequent market launch timelines.

June 29, 2026 · N/A

Topline Data

Lilly — Jaypirca

Monitor the final approval decision from the European Commission and subsequent market entry timelines.

June 27, 2026 · N/A

Topline Data

Teva — Regulatory Approval

Monitor the final approval decision and subsequent market launch timeline for Teva's Junel FE.

June 27, 2026 · N/A

Topline Data

Actavis Labs — FIORICET with Codeine

Monitor for the final approval decision and any subsequent market launch timelines.

June 26, 2026 · N/A

Topline Data

Actavis Labs — FIORICET with Codeine

Monitor for the final approval decision and any subsequent market launch timelines.

June 25, 2026 · N/A

Topline Data

Astellas Pharma Inc. — Gilteritinib

Monitor trial results and any changes in FDA approval status for gilteritinib in newly diagnosed FLT3 AML.

June 24, 2026 · N/A

Topline Data

Hikma — Solriamfetol Hydrochloride

Monitor the final approval decision and potential launch timelines for Hikma's product.

June 23, 2026 · N/A

Topline Data

Upsher Smith Labs — Isotretinoin

Watch for the final approval decision and any subsequent market entry timelines for Upsher Smith Labs' isotretinoin.

June 23, 2026 · N/A

Topline Data

AstraZeneca — Capivasertib

Monitor for the final approval decision and any subsequent market launch plans from AstraZeneca.

June 23, 2026 · N/A

Topline Data

AstraZeneca — POKONZA

Monitor for the final approval decision and any subsequent market entry timelines.

June 23, 2026 · N/A

Topline Data

— Abiraterone Acetate

Monitor the final approval decision and any subsequent market entry timelines for RISING's product.

June 22, 2026 · N/A

Topline Data

— Argatroban

Monitor the final approval decision and any subsequent market entry timelines for Argatroban.

June 21, 2026 · N/A

Topline Data

— Fosaprepitant Dimeglumine

Monitor for the final approval decision and any subsequent market entry timelines.

June 21, 2026 · N/A

Topline Data

— Pipeline Update

Monitor the progress of ongoing clinical trials targeting pediatric hypertension and any FDA approvals for new therapies in this area.

June 20, 2026 · N/A

Topline Data

TARO Pharmaceuticals — PERAMPANEL

Monitor for the final approval decision and subsequent market entry timelines for TARO's PERAMPANEL.

June 18, 2026 · N/A

Topline Data

Roche — Kadcyla

Monitor FDA approvals of new ADCs and results from ongoing advanced-stage clinical trials to gauge market shifts.

June 17, 2026 · N/A

Topline Data

AstraZeneca — Truqap

Monitor FDA's final approval decision and subsequent market launch strategies for Truqap.

June 16, 2026 · N/A

Topline Data

Roche —

Monitor the test's implementation in routine clinical practice and any forthcoming FDA approval for the US market.

June 16, 2026 · N/A

Topline Data

AstraZeneca — Camizestrant

Monitor the final approval decision from the EU and subsequent market uptake of camizestrant in combination therapies.

June 16, 2026 · N/A

Topline Data

Roche —

Monitor the uptake of Elecsys® pTau217 in clinical practice and any developments regarding FDA approval for the US market.

June 16, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor the final approval decision from the European Commission and subsequent market access strategies.

June 16, 2026 · N/A

Topline Data

AstraZeneca — Enhertu

Monitor the final approval decision from the European Commission and subsequent market access strategies.

June 2, 2026 · N/A

Related companies

Actavis Labs →

Alcon Labs →

Alembic Pharmaceuticals →

Alkem Labs →

Amgen →

Amneal Pharmaceuticals →

Amphastar Pharmaceuticals →

ANI Pharmaceuticals →

Astellas Pharma Inc. →

AstraZeneca →

Aurobindo Pharma →

Biogen →

Breckenridge Pharma →

Glenmark Pharmaceuticals →

Hetero Labs →

Hikma →

Ionis Pharmaceuticals →

Jazz Pharmaceuticals →

King Pharmaceuticals →

KNOA Pharma →

LGM Pharma →

Lilly →

Macleods Pharmaceuticals →

Merck →

Micro Labs →

Micro Labs Ltd India →

Osmotica Pharmaceuticals →

Pfizer →

Rhodes Pharmaceuticals →

Roche →

Sandoz →

Sanofi →

Saptalis Pharmaceuticals →

Sciegen Pharmaceuticals →

Strides Pharma →

Strides Pharma Intl →

Sun Pharma →

Sun Pharmaceutical Industries →

TARO Pharmaceuticals →

Teva →

Tris Pharma →

Upsher Smith Labs →

Viridian Therapeutics →

Zydus Pharmaceuticals →

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