SciClone’s Tasurgratinib NDA Accepted by NMPA for FGFR2+ Biliary Tract Cancer
SciClone Pharmaceuticals Inc. (HKG: 6600) announced that the National Medical Products Administration (NMPA) has accepted for...
Market approval filings
Hengrui Pharma’s Trastuzumab Rezetecan Filing Accepted for HER2+ Colorectal Cancer Indication
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA)...
Takeda’s Oveporexton Wins FDA Priority Review for Narcolepsy Type 1, Potential First Orexin Agonist
Takeda Pharmaceutical Company Limited (TYO: 4502, NYSE: TAK) announced that the U.S. Food and Drug Administration (FDA)...
GSK’s RSV Vaccine Filing Accepted by NMPA for China Market Entry
GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the Center for Drug Evaluation (CDE) of China’s NMPA...
Peijia Medical Files CE Mark for GeminiOne TEER System in European Mitral Regurgitation Market
Peijia Medical Ltd (HKG: 9996) announced it has submitted CE mark registration under the European...
Pfizer’s Hympavzi Wins FDA Priority Review for Pediatric Hemophilia Expansion
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted...
Fosun Pharma’s Fumaining Wins Priority Review for NF1 Adult Indication in China
Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that the National Medical Products...
AbbVie Files Rinvoq for Vitiligo Approval in US and EU
AbbVie (NYSE: ABBV) announced it has submitted new indication applications to the U.S. Food and Drug...
Datroway TNBC sBLA Gets FDA Priority Review for Triple-Negative Breast Cancer
AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that the U.S. Food and Drug Administration...
Hengrui Resubmits Camrelizumab-Apatinib BLA for HCC to FDA
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the U.S. Food and Drug Administration...
Imfinzi Gastric Cancer: AstraZeneca Secures CHMP Recommendation
AstraZeneca (AZ, NASDAQ: AZN) announced that the Committee for Medicinal Products for Human Use (CHMP) has...
Hengrui Ruitanning Gets NMPA Nod for Moderately Emetogenic Chemo Indication
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA)...
Hengrui Cancer Combo Gets NMPA Nod for Liver Cancer Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276, HKG: 1276) announced that a supplementary Biologics License Application (sBLA)...
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...
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...