CSPC’s PD-1/IL-15 Bispecific SYS6090 (JMT108) Granted FDA Fast Track for MSS/pMMR Metastatic Colorectal Cancer
CSPC Pharmaceutical Group (HKG: 1093) announced that SYS6090 (JMT108), a PD‑1/IL‑15 bispecific fusion protein, has...
Priority reviews
GSK’s Jemperli Wins FDA Priority Review for dMMR/MSI‑H Locally Advanced Rectal Cancer – PDUFA Date Set for February 2027
GlaxoSmithKline Plc (GSK, NYSE: GSK) announced that the US Food and Drug Administration (FDA) has...
Insilico Medicine’s AI-Discovered Pan-TEAD Inhibitor ISM6331 Receives FDA Fast Track Designation for Malignant Pleural Mesothelioma
Insilico Medicine (HKG: 3696) announced that ISM6331, a novel pan-TEAD inhibitor discovered through the company’s...
Roche Secures FDA Priority Review for Gazyva in Primary Membranous Nephropathy Based on Phase III MAJESTY Data
Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY) announced today that the US Food and Drug...
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...
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)...
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)...