BMS’ Camzyos Receives FDA Priority Review for Adolescent Obstructive HCM Treatment
Bristol-Myers Squibb Co. (BMS, NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA)...
Priority reviews
Sanofi’s Venglustat Receives FDA Priority Review and Breakthrough Therapy Designation for Type 3 Gaucher Disease
Sanofi (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has granted priority...
Sino Biopharmaceutical’s IDH1 Inhibitor TQB3454 Receives NMPA Priority Review for Biliary Tract Cancer
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Ltd. (HKG:...
Dizal Pharmaceutical’s Zegfrovy Receives Priority Review for First-Line EGFR Exon20ins NSCLC – Phase III WU-KONG28 Data Shows Significant PFS Benefit Over Chemotherapy
Dizal Pharmaceutical Co., Ltd. (SHA: 688192) announced that China’s Center for Drug Evaluation (CDE) has...
Jiangsu Chia Tai Tianqing Secures NMPA Priority Review for LM-302 ADC in CLDN18.2-Positive Gastric Cancer
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Ltd (HKG:...
Bayer’s Asundexian Receives FDA Priority Review for Secondary Stroke Prevention Following Positive Phase III OCEANIC-STROKE Trial
Bayer AG (ETR: BAYN) announced today that the U.S. Food and Drug Administration (FDA) has...
Bayer’s HYRNUO Receives FDA Priority Review for First-Line HER2-Mutated NSCLC Treatment
Bayer AG (ETR: BAYN) announced that the U.S. Food and Drug Administration (FDA) has granted...
CanSino Biologics’ Five-Component Pertussis Vaccine Enters NMPA Priority Review for Ages 6+
CanSino Biologics Inc. (HKG: 6185) announced that China’s National Medical Products Administration (NMPA) has included...
BeOne Medicines’ Tislelizumab-Zanidatamab Combo Receives FDA Priority Review for HER2-Positive Gastric Cancer
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), formerly BeiGene, announced that the U.S....
GSK’s Efimosfermin Receives Dual Regulatory Designations for MASH Treatment – Breakthrough Therapy and PRIME Status Support Phase III Development
GlaxoSmithKline plc (GSK, NYSE: GSK) announced on April 27, 2026, that efimosfermin, a once-monthly investigational...
Daiichi Sankyo-Merck Ifinatamab Deruxtecan Granted FDA Priority Review for Extensive-Stage SCLC
Daiichi Sankyo (TYO: 4568) and Merck & Co., Inc. (MSD; NYSE: MRK) announced that the...
InnoCare’s Zurletrectinib Wins Priority Review for Pediatric NTRK Tumors – Next‑Gen TRK Inhibitor Expands Label
InnoCare Pharma Limited (SHA: 688428, HKG: 9969) announced that the Center for Drug Evaluation (CDE) of China’s...
Hengrui’s ANGPTL3 Antibody SHR-1918 NDA Accepted by NMPA – Priority Review for Rare Disease HoFH
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that China’s 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)...
TYK Medicines Asandeutertinib Gets China Priority Review for NSCLC Brain Metastases
TYK Medicines, Inc. (HKG: 2410) announced that its Category 1 drug asandeutertinib (TY‑9591), a third‑generation EGFR...
Nanjing Leads Biolabs Secures FDA Fast Track for LBL-034 in Multiple Myeloma
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that LBL-034, a GPRC5D/CD3 bispecific antibody (BsAb) T‑cell...
Sichuan Biokin’s BL-B01D1 ADC Wins Priority Review for ESCC in China
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced that iza-bren (izalontamab brengitecan, BL-B01D1), its first‑in‑class...
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...
NMPA Releases 2025 Priority Approval Directory for Eight High-End Medical Device Categories
China’s National Medical Products Administration (NMPA) published the 2025 Edition of the Directory of High-End...
BeOne Medicines Wins FDA Fast Track for GPC3 Bispecific in Liver Cancer
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that the U.S. Food and Drug...