Shandong Boan Biotech Submits BLA to Brazil’s ANVISA for Aflibercept Biosimilar BA9101, Expanding Global Ophthalmic Footprint
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced the submission of a Biologics License Application...
Market approval filings
CSPC Pharmaceutical’s NDA for Anbenitamab-HB1801 Combination Accepted by China NMPA as Neoadjuvant Therapy for HER2+ Breast Cancer
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the New Drug Application (NDA) for its...
Allergan Aesthetics’ BOTOX Cosmetic sBLA Accepted by FDA for Masseter Muscle Prominence, Poised to Become First Neurotoxin Indication
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), announced that the U.S. Food and Drug...
Sino Biopharmaceutical’s BCL-2 Inhibitor TQB3909 Tablet Receives CDE Acceptance for CLL/SLL Treatment in Relapsed/Refractory Patients
Sino Biopharmaceutical Limited (HKG: 1177) announced that its subsidiary Chia Tai Tianqing Pharmaceutical (CTTQ)‘s New...
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...
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...