CDE Lists Five Drugs and One Companion Diagnostic for Priority Review Status
The Center for Drug Evaluation (CDE) has indicated on its website that five investigational drugs...
Priority reviews
Sinopharm and Ruidio Pharmaceutical Advance in Priority Review for Innovative Drugs and Vaccines
BEIJING—The Center for Drug Evaluation (CDE) has indicated that two Chinese companies, Foshan Ruidio Pharmaceutical...
Kelun Pharmaceutical’s Sacituzumab Tirumotecan Receives Priority Review for NSCLC Treatment
Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) has announced that its drug sacituzumab tirumotecan (SKB264/MK-2870)...
Wantai Biological’s HPV Vaccine Receives Priority Review from China’s CDE
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced that its nine-valent recombinant...
Belief BioMed’s Hemophilia B Gene Therapy BBM-H901 Slated for Priority Review in China
The Center for Drug Evaluation (CDE) has indicated on its website that the market application...
HutchMed’s Tazverik for Follicular Lymphoma Accepted for Review by China’s NMPA
HutchMed (NASDAQ: HCM), a China-based biopharmaceutical company, has announced that the National Medical Products Administration...
Johnson & Johnson’s Talvey Gets Green Light in South Korea for Multiple Myeloma
Johnson & Johnson (J&J; NYSE: JNJ) has announced that its subsidiary Janssen Korea has received...
InnoCare’s Tafasitamab-Lenalidomide Combo on Track for Priority Review in China for DLBCL Treatment
The Center for Drug Evaluation (CDE) website has indicated that InnoCare (HKG: 9969; SHA: 688428),...
Keymed Biosciences’ Stapokibart Earns Priority Review for Chronic Sinusitis Treatment in China
Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced that its...
Jacobio Pharma’s Gecirasib Gets Priority Review for NSCLC Treatment by China’s NMPA
Jacobio Pharma (HKG: 1167), a leading biopharmaceutical company based in China, has announced that its...
Shanghai Fosun Pharma’s FCN-159 Receives Priority Review for Pediatric Neurofibromatosis Treatment
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has achieved a significant milestone...
Roche’s Inavolisib Earns Priority Review Status in China for PIK3CA-Mutated Breast Cancer
Swiss pharmaceutical giant Roche (SWX: ROG) has received priority review status from China’s Center for...
Guangzhou and Zhuhai Unveil Measures to Stimulate Biopharmaceutical Industry Growth
In a bid to bolster the biopharmaceutical and health industries, the cities of Guangzhou and...
Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
Alexion, the rare disease unit of AstraZeneca (AZ; NASDAQ: AZN) based in the UK, has...
J&J’s Nipocalimab Fast-Tracked by FDA for Reducing FNAIT Risk in Pregnant Adults
The US Food and Drug Administration (FDA) has accepted Johnson & Johnson’s (J&J; NYSE: JNJ)...
Pfizer’s Elrexfio Anticipated for Priority Review in China for Relapsed/Refractory Multiple Myeloma
The Center for Drug Evaluation (CDE) in China has indicated that Pfizer (NYSE: PFE)’s Elrexfio...
Innovent and HutchMed’s Combination Therapy Set for Priority Review in China for Advanced Endometrial Cancer
China’s Center for Drug Evaluation (CDE) has indicated that the combination therapy of Innovent Biologics...
Lepu Biotechnology’s MRG004A ADC Gains Fast Track Designation for Pancreatic Cancer
Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed...
BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY)...
Xian Janssen’s Tremfya Heads for Priority Review in China for Crohn’s Disease Treatment
The Center for Drug Evaluation (CDE) has indicated that Xian Janssen Pharmaceutical’s Tremfya (guselkumab), an...