Fosun Kite’s Yescarta Gains Priority Review Status for r/r LBCL
China-based Fosun Kite Biotechnology Co., Ltd, a joint venture (JV) between Shanghai Fosun Pharmaceutical (Group)...
Priority reviews
CARsgen’s BCMA-Targeted CAR-T Therapy CT053 Gains Priority Review in China
The Center for Drug Evaluation (CDE) website indicates that China-based chimeric antigen receptor (CAR)-T cell...
Tris Pharma and Pediatrix Therapeutics’ ADHD Drug Gains Priority Review in China
The Center for Drug Evaluation (CDE) has indicated that the methylphenidate hydrochloride oral sustained-release dry...
Hengrui Medicine’s Dexmedetomidine Nasal Spray Gains Priority Review
China’s Center for Drug Evaluation (CDE) has indicated that Hengrui Medicine Co., Ltd’s (SHA: 600276)...
CDE Prioritizes Review of Pearl Bio’s Breatinib for NSCLC Treatment
The Center for Drug Evaluation (CDE) website indicates that Beijing Pearl Biotechnology Co., Ltd’s APL-101/PLB1001...
InnoCare Pharma and CStone Pharmaceuticals’ Drugs Receive Prioritized CDE Review
The Center for Drug Evaluation (CDE) has granted prioritized review status to InnoCare Pharma’s (HKG:...
Viatris Pharmaceuticals’ HIV/AIDS Drug Prioritized for CDE Review
The Center for Drug Evaluation (CDE) has indicated that Viatris Pharmaceuticals Co., Ltd’s efavirenz/lamivudine/tenofovir is...
Grand Pharmaceutical’s Carglumic Acid Set for Priority Review by CDE
The Center for Drug Evaluation (CDE) website indicates that China-based Grand Pharmaceutical Group Limited’s (HKG:...
CDE Prioritizes Review for Sanofi’s Nexviazyme and WinHealth’s Ravicti
The Center for Drug Evaluation (CDE) website indicates that two drugs have been selected for...
Tris Pharma and Pediatrix’s Methylphenidate Tablet, Ipsen’s Triptorelin Injection Awarded Priority Review by CDE
The Center for Drug Evaluation (CDE) website shows that US-based Tris Pharma and Pediatrix Therapeutics’...
CDE Grants Priority Review to Ascentage’s Olerembatinib and Roche’s Crovalimab
The Center for Drug Evaluation (CDE) has granted priority review status to two drugs: Suzhou...
Sobi’s Anakinra (Kineret) Prioritized for Review in China for FMF Treatment
The Center for Drug Evaluation (CDE) website indicates that Swedish Orphan Biovitrum AB’s (Sobi; BMV:...
Takeda’s Obizur Prioritized for Review in Acquired Hemophilia A Treatment
The Center for Drug Evaluation (CDE) website indicates that Takeda Pharmaceutical Co., Ltd’s Obizur (susoctocog...
Sichuan Meida’s Phentolamine Gains Priority Review for Pheochromocytoma Treatment
The Center for Drug Evaluation (CDE) website indicates that Sichuan Meida Kangjiale Pharmaceutical Co., Ltd’s...