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...
Priority reviews
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)...
CanSino Biologics’ DTcP Vaccine for Infants Gains Priority Review in China
China-based vaccines specialist CanSino Biologics Inc. (HKG: 6185) announced that the New Drug Application (NDA)...
Boehringer Ingelheim’s Nerandomilast Granted Priority Review for IPF in China
German pharmaceutical giant Boehringer Ingelheim has announced that the Center for Drug Evaluation (CDE) of...
FDA Grants Priority Review to Johnson & Johnson’s Nipocalimab for Myasthenia Gravis
US-based Johnson & Johnson (J&J, NYSE: JNJ) has announced that the US FDA has granted...
Dizal’s Sunvozertinib Receives Priority Review from FDA for EGFR Exon 20 NSCLC
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its New Drug Application (NDA)...
Huahui Health’s HH-003 Gains Priority Review Status for Chronic Hepatitis D Treatment
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has indicated...
CDE Indicates Priority Review for Boehringer Ingelheim’s Zongertinib and Peers
The China’s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German...
GSK’s Blenrep and Star Pharma’s Topiramate Solution Target Priority Review in China
The China’s Center for Drug Evaluation (CDE) website has signaled that GlaxoSmithKline’s (GSK; NYSE: GSK)...