Jinling Pharmaceutical’s Ferric Carboxymaltose Injection Receives NMPA Acceptance for Market Authorization
Jinling Pharmaceutical Co., Ltd. (SHE: 000919) announced that the marketing authorization application for its Ferric...
Market approval filings
Hengrui Pharmaceuticals’ HER3-Targeting ADC Ruzaltatug Rezetecan Receives NMPA Marketing Application Acceptance for EGFR-Mutant NSCLC Post-TKI Progression
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the marketing authorization application...
CSPC’s Albumin-Bound Sirolimus Receives NMPA Breakthrough Therapy Designation for Rare PEComa Tumor
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the marketing application for its self-developed Class...
Roche’s Susvimo Receives CHMP Recommendation for Neovascular AMD with Contivue Implant Delivery System
Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY) announced that the European Medicines Agency’s Committee for...
Pfizer Secures FDA Priority Review for TALZENNA-XTANDI Combination in Earlier-Stage Prostate Cancer
Pfizer Inc. (NYSE: PFE) announced on July 22, 2026 that the U.S. Food and Drug...
Junshi Biosciences Receives NMPA Acceptance for Toripalimab Expanded Indication in Resectable Stage II–III NSCLC
Junshi Biosciences (HKG: 1877, SHA: 688180) announced that the National Medical Products Administration (NMPA) has...
Haisco Submits NMPA Marketing Application for Crisugabalin’s New Indication in Neuropathic Pain Treatment
Haisco Pharmaceutical Group Co., Ltd. (SHE: 002653) announced that it has submitted a marketing application...
Sino Biopharmaceutical Submits China Marketing Application for World’s First Intra-Incisional Long-Acting Ropivacaine Analgesic
Sino Biopharmaceutical Limited (HKG: 1177) announced that its subsidiary, Beijing Tide Pharmaceutical, has submitted a...
Hengrui Pharmaceuticals Secures NMPA Priority Review for Trastuzumab Rezetecan in HER2-Low Breast Cancer, Expanding Third Indication in China
Hengrui Pharmaceuticals (SHA: 600276; HKG: 1276) announced that China’s National Medical Products Administration (NMPA) has...
Hengrui Pharmaceuticals Secures NMPA Priority Review for Trastuzumab Rezetecan in HER2-Low Breast Cancer, Expanding Third Indication in China
Hengrui Pharmaceuticals (SHA: 600276; HKG: 1276) announced that China’s National Medical Products Administration (NMPA) has...
Juventas Cell Therapy’s CAR-T Therapy Yuanruida Receives HSA Filing Acceptance for r/r B-ALL – Expanding Global Regulatory Footprint Following NMPA Approval
Juventas Cell Therapy Ltd. announced that the New Drug Application (NDA) for Yuanruida (inaticabtagene autoleucel),...
Hybio Pharma’s Generic Tirzepatide ANDA Accepted by FDA – First-to-File Challenger Targets $20B+ Dual GLP-1/GIP Agonist Franchise with Paragraph IV Certification
Shenzhen Hybio Pharmaceutical Co., Ltd. (SHE: 300199) announced today that the U.S. Food and Drug...
Roche Receives FDA Priority Review for Enspryng in Thyroid Eye Disease – IL-6 Inhibitor Leverages Novel Recycling Technology for Second Indication
Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY) announced today that the U.S. Food and Drug...
J&J’s TECVAYLI-Daratumumab Combo Receives CHMP Recommendation for Earlier Multiple Myeloma Treatment Line
Johnson & Johnson (J&J, NYSE: JNJ) announced on June 26, 2026, that the Committee for...
Hengrui’s Rezvilutamide Receives EMA Acceptance for Metastatic Prostate Cancer Treatment
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the European Medicines Agency...
Roche’s Lunsumio-Polatuzumab Combination Accepted for FDA Review in Relapsed/Refractory Large B-Cell Lymphoma
Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration...
CSPC Pharmaceutical’s Efmedaglutide Alfa GLP-1 Therapy Accepted for NMPA Review in Type 2 Diabetes Indication
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has...
CSPC Pharmaceutical’s Cosentyx Biosimilar Accepted for NMPA Review in China’s Competitive IL-17A Market
CSPC Pharmaceutical Group (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has accepted...
Gilead Sciences Submits sNDA for Once-Weekly Oral Yeztugo PrEP – Potential First Long-Acting Oral HIV Prevention Option
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the U.S. Food and Drug Administration (FDA) has...
Sichuan Biokin’s Iza-Bren Becomes World’s First EGFR×HER3 Bispecific ADC with NDA Accepted by China’s NMPA
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that the new drug application (NDA) for...