Small Molecule

Boehringer Ingelheim's Zongertinib NDA219042 Receives AP Status from FDA

The FDA has granted an Approval Pending (AP) status for Boehringer Ingelheim's supplemental NDA for Zongertinib.

Pfizer Raises 2026 Revenue Guidance by $500 Million Amid Strong Q2 Results

Pfizer reported a 3% increase in Q2 2026 revenues, raising its full-year revenue guidance by $500 million due to strong performance in non-COVID products.

Cipla's Lenalidomide ANDA210435 Receives Abbreviated Approval from FDA

Cipla's application ANDA210435 for Lenalidomide has received an abbreviated approval status from the FDA.

FDA Approves Pomalidomide Supplement by Breckenridge

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

FDA Accepts Supplement Application for Lenalidomide by Biocon Pharma

The FDA has accepted a supplemental application for lenalidomide submitted by Biocon Pharma.

FDA Grants AP Status for Lenalidomide ANDA210480 by Alvogen

The FDA has granted Abbreviated Approval (AP) status for Alvogen's ANDA210480 for lenalidomide.

FDA Accepts Lenalidomide Supplement Application from Amneal

The FDA has accepted a supplemental application for lenalidomide (ANDA216213) submitted by Amneal.

FDA Approves Lenalidomide Supplement Application by Sun Pharma

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

Apotex submits supplemental application for Pomalidomide (ANDA 210164)

Apotex has submitted a supplemental application for Pomalidomide under ANDA 210164.

FDA Accepts Lenalidomide ANDA Submission from Torrent

The FDA has accepted the ANDA submission for Lenalidomide from Torrent Pharmaceuticals.

Cipla's Lenalidomide ANDA214618 Receives FDA AP Status

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

FDA Accepts Supplemental Application for Pomalidomide by Hetero Labs

The FDA has accepted a supplemental application for pomalidomide submitted by Hetero Labs.

Eugia Pharma submits supplemental application for Pomalidomide (ANDA210249)

Eugia Pharma has submitted a supplemental application for Pomalidomide under ANDA210249, currently marked as AP.

FDA Accepts Supplement Application for Lenalidomide by Arrow International

The FDA has accepted a supplemental application for lenalidomide submitted by Arrow International.

FDA Accepts Supplemental Application for Pomalidomide by Teva Pharmaceuticals

Teva Pharmaceuticals has submitted a supplemental application for Pomalidomide, which is currently under review by the FDA.

FDA Grants Approval for Pomalidomide Supplement by Mylan

The FDA has granted approval for a supplemental application for Pomalidomide submitted by Mylan.

FDA Grants AP Status for Lenalidomide ANDA217265 by QILU

The FDA has granted approval status (AP) for ANDA217265, a supplemental application for lenalidomide submitted by QILU.

EUGIA PHARMA's Lenalidomide ANDA213885 Receives AP Status from FDA

EUGIA PHARMA's application for Lenalidomide (ANDA213885) has received an Abbreviated Approval (AP) status from the FDA.

FDA Accepts Lenalidomide Supplement Application from Novugen

The FDA has accepted a supplemental application for Lenalidomide (ANDA217281) submitted by Novugen.

FDA Accepts Lenalidomide Supplement Application from Apotex

The FDA has accepted the supplemental application ANDA211022 for lenalidomide submitted by Apotex.

FDA Grants AP Status for Lenalidomide ANDA213912 by Mylan

The FDA has granted approval status (AP) for Mylan's abbreviated new drug application (ANDA) for lenalidomide.

FDA Acceptance of Lenalidomide Supplement Application by Hetero Labs

The FDA has accepted the supplemental application ANDA212414 for lenalidomide submitted by Hetero Labs.

FDA Accepts Supplement Application for Lenalidomide by Dr. Reddy's

The FDA has accepted a supplemental application for lenalidomide submitted by Dr.

Lupin's Lenalidomide ANDA214398 Receives FDA Approval Status

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

FDA Approves JIDEYTRO (ZIDESAMTINIB) for Nuvalent Inc.

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

Karyopharm's XPOVIO (Selinexor) NDA212306 Receives Approval Status from FDA

The FDA has granted approval status (AP) for Karyopharm's NDA212306 for XPOVIO (Selinexor).

Incyte's INCA33890 Safety Study in Advanced Solid Tumors Initiated

Incyte Corporation is conducting a study to evaluate the safety and tolerability of INCA33890 in patients with advanced or metastatic solid tumors.

FDA Accepts Supplement for OJJAARA (Momelotinib Dihydrochloride) by GlaxoSmithKline

The FDA has accepted a supplemental application for OJJAARA, indicating progress in its regulatory pathway.

FDA Approves Supplemental Application for OGSIVEO (Nirogacestat Hydro bromide)

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

Sandoz submits ANDA for Pemigatinib, seeking FDA approval

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

FDA Accepts Application for CAVHANZA (Nilotinib) by FLEX PHARMA

The FDA has accepted the New Drug Application (NDA) for CAVHANZA, a nilotinib-based treatment.

Hutchmed Initiates Study on Food and PPI Effects on HMPL-760 Pharmacokinetics

Hutchmed is conducting a pharmacokinetics study of HMPL-760, evaluating food and proton pump inhibitor effects.

FDA Accepts Nintedanib Application from Glenmark Pharmaceuticals

The FDA has accepted the application for Nintedanib (ANDA212555) from Glenmark Pharmaceuticals.

FDA Grants Approval for Nintedanib Esylate ANDA218472

The FDA has granted approval for the ANDA218472 application for Nintedanib Esylate submitted by Humanwell Puracap.

BeOne Medicines initiates trial for BG-75098 in advanced solid tumors

A clinical trial is underway to assess the safety and efficacy of BG-75098, both alone and in combination with other agents.

Phase I Study of [14C]Zorifertinib Shows Promising Safety and Pharmacokinetics

[14C]Zorifertinib is undergoing Phase I study to evaluate its safety and pharmacokinetics in healthy males.

Apotex submits supplemental ANDA for Pomalidomide

Apotex has submitted a supplemental abbreviated new drug application (ANDA) for Pomalidomide.

FDA Acceptance of Lenalidomide Supplement by Alvogen

The FDA has accepted the supplemental application for Lenalidomide submitted by Alvogen.

FDA Accepts Supplement for Lenalidomide by Biocon Pharma

The FDA has accepted a supplemental application for Lenalidomide submitted by Biocon Pharma.

Amneal's Lenalidomide ANDA216213 Receives Abbreviated Approval

Amneal's abbreviated new drug application (ANDA216213) for Lenalidomide has received approval from the FDA.

FDA Accepts Supplement Application for Lenalidomide by Accord Healthcare

The FDA has accepted a supplemental application for Lenalidomide submitted by Accord Healthcare.

FDA Approves ANDA for Pomalidomide by Hetero Labs

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

FDA Accepts Lenalidomide ANDA217281 Submission from Novugen

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Lenalidomide submitted by Novugen.

Novartis initiates ascending dose study of PIT565 for rheumatoid arthritis

Novartis is conducting a study to evaluate the safety, tolerability, and pharmacokinetics of PIT565 in rheumatoid arthritis patients.

FDA Acceptance of Lenalidomide Supplement Application by Mylan

The FDA has accepted Mylan's supplemental application for Lenalidomide under ANDA213912.

FDA Accepts Supplement Application for Lenalidomide by Dr. Reddy's

The FDA has accepted a supplemental application for lenalidomide submitted by Dr.

Cipla's Lenalidomide ANDA213165 Receives AP Status from FDA

Cipla's Abbreviated New Drug Application (ANDA) for Lenalidomide has received an Approval Pending (AP) status from the FDA.

Karyopharm's XPOVIO (Selinexor) NDA Supplement Receives Approval from FDA

The FDA has approved the NDA supplement for Karyopharm's XPOVIO (Selinexor), indicating a successful submission.

FDA Accepts Supplement for Romvimza (Vimselitinib) by Deciphera Pharmaceuticals

The FDA has accepted a supplemental NDA for Romvimza (Vimselitinib) from Deciphera Pharmaceuticals.

Phase 1 Study of YZJ-5053 Tablets in Advanced Solid Tumors Initiated

A Phase 1 clinical trial is underway to assess the safety and efficacy of YZJ-5053 tablets in patients with advanced solid tumors.

Phase I/II Study of LBL-024 in Advanced Malignant Tumors Initiated by Nanjing Leads Biolabs

Nanjing Leads Biolabs has initiated Phase I/II clinical trial for LBL-024 targeting advanced malignant tumors.

FDA Accepts Supplemental NDA for Romvimza (Vimselitinib) by Deciphera Pharmaceuticals

The FDA has accepted a supplemental NDA for Romvimza (vimselitinib) submitted by Deciphera Pharmaceuticals.

Phase 2a Trial of KDS2010 in Obesity Shows Promising Efficacy and Safety Profile

Phase I Trial of LNF2105 Shows Promise in Advanced Solid Tumors

A Phase I clinical trial is underway to evaluate LNF2105 in patients with advanced solid tumors, focusing on safety and preliminary efficacy.

Deucravacitinib shows promise in Pityriasis Rubra Pilaris study by Mayo Clinic

A study is underway to evaluate the safety and effectiveness of Deucravacitinib in patients with Pityriasis Rubra Pilaris.

FDA Accepts Supplement for Vorasidenib (Voranigo) by Servier

The FDA has accepted a supplemental application for Vorasidenib (Voranigo) from Servier.

FDA Grants Priority Review for Welireg Supplement from Merck

The FDA has granted priority review for the supplemental NDA for Welireg (belzutifan) submitted by Merck.

Deciphera's Vimseltinib Study Evaluates Interaction with Oral Contraceptives

A clinical trial is underway to assess how vimseltinib affects the pharmacokinetics of a combined oral contraceptive.

FDA Grants Priority Review for Welireg Supplement NDA215383

The FDA has granted priority review for the supplemental NDA for Welireg (belzutifan) submitted by Merck Sharp Dohme.

Merck's Acquisition of Terns Pharmaceuticals Advances as HSR Waiting Period Expires

Merck's acquisition of Terns Pharmaceuticals progresses as the HSR waiting period has expired, allowing the tender offer to move forward.