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....
Priority reviews
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...
Neurodawn’s Y-4 Wins FDA Fast Track for First‑in‑Class Neuropathic Pain Combo
Neurodawn Pharmaceutical Co., Ltd. announced that its Y‑4 tablet received Fast Track Designation (FTD) from...
TransThera Tinengotinib Cholangiocarcinoma Priority Review China
TransThera Sciences (Nanjing) Inc. (HKG: 2617) announces that Tinengotinib tablets have been included in the...
MSD MK-2214 Fast Track Alzheimer Data Positive
Merck Sharp & Dohme Inc. (MSD, NYSE: MRK) released first‑in‑human data for MK-2214 and MK-1167 in...
AbbVie Rinvoq upadacitinib CDE Priority Review Alopecia Areata China
AbbVie (NYSE: ABBV) announced that Rinvoq (upadacitinib) has been included in the priority review list...
US FDA’s CNPV Fast‑Track Program Expands to 15 Drugs, Cutting Review Time to Months
The Commissioner’s National Priority Voucher (CNPV) pilot has just added 15 therapies to its two‑batch...
AbbVie Secures NMPA Priority Review for Epcoritamab in Relapsed Follicular Lymphoma
American pharmaceutical giant AbbVie (NYSE: ABBV) disclosed that its bispecific T‑cell engager, epcoritamab, has been...
Daiichi Sankyo’s Enhertu Submitted for Priority Review in China for HER2-Positive Breast Cancer
On August 22, 2025, Daiichi Sankyo (TYO: 4568) submitted a marketing authorization application for Enhertu...
Dizal Pharma’s DZD8586 Granted FDA Fast Track Designation for CLL/SLL Treatment
Dizal (Jiangsu) Pharmaceutical Co., Ltd (SHA: 688192) announced that its investigational product DZD8586 has been...