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...
Priority reviews
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...
Daiichi Sankyo and AstraZeneca Submit Enhertu Application for HER2-Positive Gastric Cancer in China
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have submitted a supplemental new-drug application...
Allist’s Furmonertinib Granted Priority Review for EGFR Exon 20 NSCLC in China
Shanghai-based biotech Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced that its Category 1 small molecule...
MSD’s Winrevair Accepted for Priority Review by FDA for Pulmonary Arterial Hypertension
US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) announced that the US Food...
TransThera Sciences’ Tinengotinib Gains FDA Fast Track for mCRPC Treatment
China-headquartered TransThera Sciences (Nanjing) Inc., (HKG: 2617), which listed in Hong Kong this week, announced...
FDA Launches Commissioner’s National Priority Voucher Program for Accelerated Drug Reviews
The U.S. Food and Drug Administration (FDA) this week announced the launch of the Commissioner’s...
CDE Accepts NDA for Ark Bio’s Azstarys, a Priority-Reviewed ADHD Treatment
China’s Center for Drug Evaluation (CDE) has officially accepted the New Drug Application (NDA) for...
Sanofi’s Rilzabrutinib Shows Promise in IgG4-Related Disease Trial
French pharmaceutical giant Sanofi (NASDAQ: SNY) announced positive results from a Phase II study of...