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...
Priority reviews
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...