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...
Priority reviews
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...
CARsgen’s Satricabtagene Autoleucel Granted Priority Review by China’s CDE
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the Center for Drug Evaluation...
Abbisko’s Pimitinib Granted Priority Review for TGCT Treatment in China
Abbisko Therapeutics Co., Ltd (HKG: 2256) announced that its self-developed, highly selective small-molecule CSF-1R inhibitor,...
Zai Lab’s ZL-1310 Receives FDA Fast Track Designation for SCLC
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received Fast...
Regeneron’s Eylea HD Receives FDA Priority Review for Macular Edema Treatment
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGNN) announced that the U.S. Food and Drug Administration (FDA) has...
Takeda’s Adzynma, BeiGene’s Sonrotoclax, and Avistone’s Andatinib Set for Priority Review in China
The website of China’s Center for Drug Evaluation (CDE) indicates that Takeda’s (TYO: 4502) Adzynma...
Sanofi’s mRNA Chlamydia Vaccine Gains FDA Fast Track Designation
French pharmaceutical giant Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving fast track designation from...
Sanofi’s Tolebrutinib Accepted for FDA Review in Non-Relapsing Secondary Progressive Multiple Sclerosis
Sanofi (EPA: SAN, NASDAQ: SNY) announced that a market filing for its tolebrutinib as a...
Coherent Biopharma’s CBP-1019 Granted FDA Fast Track Status for Endometrial Cancer
Coherent Biopharma Ltd, a Suzhou-based specialist in bispecific-ligand drug conjugates (Bi-XDC), announced that the U.S....
Innovent Biologics’ Ipilimumab NDA Accepted by CDE with Priority Review for Colon Cancer
China-based Innovent Biologics, Inc. (HKG: 1801) announced that the Center for Drug Evaluation (CDE), National...
Boehringer Ingelheim’s Zongertinib NDA Accepted by FDA for HER2-Mutated NSCLC
Germany-based Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has accepted its...
Sanofi’s Dupixent Receives Priority Review from FDA for Bullous Pemphigoid Treatment
Sanofi (EPA: SAN, NASDAQ: SNY) announced that the US Food and Drug Administration (FDA) has...
Gilead Sciences’ Lenacapavir NDA for HIV Prevention Accepted by FDA for Priority Review
US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that the New Drug Application (NDA) for its...
Hansoh Pharma’s Uplizna Receives Priority Review for IgG4-RD Treatment
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that the National Medical Products Administration (NMPA)...