BioArctic Partner Eisai Submits EMA Application for Four-Week Lecanemab Dosing in Alzheimer’s
BioArctic AB (OTCMKTS: BRCTF) partner Eisai (TYO: 4523) announced submission of a proposed Marketing Authorisation Variation...
Market approval filings
Nuance Pharma Secures NMPA Review for Ensifentrine COPD Maintenance Therapy
Nuance Pharma announced that its market filing for Ohtuvayre (ensifentrine) as maintenance treatment for patients...
Eisai/Biogen’s LEQEMBI Autoinjector Wins FDA Priority Review for Weekly Alzheimer’s Dosing
Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) announced that the U.S. Food and Drug...
HeartCare Medical’s Intracranial Drug‑Eluting Stent Gets NMPA Filing Nod
Shanghai HeartCare Medical Technology Co., Ltd (HKG: 6609) announced that China’s National Medical Products Administration...
Biokin’s Iza-bren ADC Receives NMPA Filing Acceptance for ESCC, World’s First EGFR×HER3 Bispecific
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that China’s National Medical Products Administration (NMPA)...
Grand Pharmaceutical Files TLX591-CDx PSMA Diagnostic for Prostate Cancer in China
Grand Pharmaceutical Group Limited (HKG: 0512) announced it has filed TLX591-CDx (Illuccix, gallium Ga 68...
Akeso’s Gumokimab NMPA Filing for Ankylosing Spondylitis Expands IL‑17A Franchise
Akeso Biopharma (HKG: 9926) announced that the Center for Drug Evaluation (CDE) of NMPA has...
Henlius’s HANBEITAI Bevacizumab Biosimilar BLA Accepted by FDA for Multiple Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the U.S. Food and Drug Administration (FDA)...
CSPC’s Prusogliptin/Metformin FDC NDA Accepted by NMPA for Type 2 Diabetes, Targeting 60 M Underserved Patients
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced that China’s National Medical Products Administration (NMPA) has accepted...
Lifetech’s CS Stent System Wins NMPA Fast‑Track for Aortic Arch Aneurysms, Eliminates Cerebral Ischemia Risk
Lifetech Scientific Corporation (HKG: 1302) announced that its Concave Supra (CS) integrated aortic arch triple‑branch reconstruction...
Merck and Abbisko’s Pimicotinib NDA Accepted by FDA for TGCT, Building on China Approval
Merck KGaA (ETR: MRK) and Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced that the U.S. FDA...
Summit Therapeutics Submits Ivonescimab BLA to FDA for EGFR‑Mutated NSCLC Post Third‑Gen TKI
Summit Therapeutics (NASDAQ: SMMT), the US partner of Akeso Inc. (HKG: 9926), announced the submission of...
Broncus Medical Secures NMPA Fast‑Track for BroncTarget COPD System, Targeting 9 Million Refractory Patients in China
Broncus Medical (HKG: 2216) announced that China’s National Medical Products Administration (NMPA) has granted fast‑track designation...
Alphamab Oncology Submits Envafolimab for First‑Line Biliary Tract Cancer (BTC) as World’s First Subcutaneous PD‑L1
Alphamab Oncology (HKG: 9966) announced that China’s National Medical Products Administration (NMPA) has accepted its marketing...
Dongcheng Pharma’s PSMA PET Agent [18F] Spiritide NDA Accepted by NMPA
Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced that the New Drug Application (NDA)...
Genrix Bio’s GR1803 NDA Accepted for BCMA-Targeted Multiple Myeloma Therapy
Chongqing Genrix Biopharmaceutical Co., Ltd (SHA: 688443) announced that the conditional New Drug Application (NDA)...
Takeda and Protagonist Submit Rusfertide NDA for Polycythemia Vera
Takeda Pharmaceutical Company Limited (TYO: 4502, NYSE: TAK) and Protagonist Therapeutics, Inc. (NASDAQ: PTGX) announced...
Sanofi’s Tzield Wins FDA Priority Review for Pediatric T1D Expansion
Sanofi (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has accepted for...
HutchMed’s Savolitinib NDA Accepted by NMPA for MET-Amplified Gastric Cancer with Priority Review
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced that China’s National Medical Products Administration (NMPA)...
Recbio’s REC610 Shingles Vaccine NDA Accepted by NMPA, Challenging GSK’s Shingrix
Jiangsu Recbio Technology Co., Ltd. (HKG: 2179) announced that the New Drug Application (NDA) for...