BeiGene’s ZW25 on Track for Priority Review for Cholangiocarcinoma Treatment by CDE
The Center for Drug Evaluation (CDE) website has indicated that BeiGene’s (NASDAQ: BGNE) ZW25 (zanidatamab)...
Priority reviews
Sichuan Kelun-Biotech’s SKB264 Receives Priority Review Status for TNBC Treatment in China
The China’s Center for Drug Evaluation (CDE) website has indicated that Sichuan Kelun-Biotech Biopharmaceutical Co.,...
Jenscare Scientific’s Ken Valve Enters NMPA Priority Review for Aortic Valve System
Jenscare Scientific Co., Ltd (HKG: 9877), a leading structural heart disease device manufacturer based in...
Innovent Biologics’ GFH925 on Track for Priority Review Status for NSCLC Treatment
The Center for Drug Evaluation (CDE) has indicated that Innovent Biologics’s (HKG: 1801) Category 1...
CDE Grants Priority Review to Pearl Biotech’s Breatinib for Glioblastoma Treatment
China’s Center for Drug Evaluation (CDE) has indicated that Beijing Pearl Biotechnology Co., Ltd’s breatinib...
Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE)...
FDA Grants Priority Review to MSD’s Welireg for Advanced RCC Indication Extension
The US Food and Drug Administration (FDA) has granted priority review status to an indication...
Henan Zhongshuai’s Dexmethylphenidate Hydrochloride Capsules Target Priority Review for Pediatric ADHD
Henan Zhongshuai Pharmaceutical Co., Ltd., a China-based pharmaceutical company, is poised to secure priority review...
Novo Nordisk’s Esperoct on Track for Priority Review in Hemophilia A Treatment
The Center for Drug Evaluation (CDE) website has indicated that Denmark-based Novo Nordisk’s (NYSE: NVO)...
Dizal Pharmaceutical’s Golidocitinib Earns Priority Review for r/r PTCL Treatment in China
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that its drug golidocitinib has been...
Akeso Biopharma’s Ivonescimab Heads for Priority Review for NSCLC Treatment
China-based Akeso Biopharma (HKG: 9926) has announced that its bispecific antibody (BsAb) ivonescimab (AK112), targeting...
FDA Grants Priority Review to Pfizer and Astellas’ Xtandi for High-Risk Prostate Cancer
The US Food and Drug Administration (FDA) has granted priority review status to the submission...
J&J’s Teclistamab Granted Priority Review in China for Relapsed Multiple Myeloma
The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson’s (J&J, NYSE:...
Cutia Therapeutics’ CU-10201 Enters Priority Review for Acne Treatment in China
Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has announced that its CU-10201, a 4% minocycline...
Chipscreen Pharmaceutical’s Epidaza Granted Priority Status for DLBCL Treatment in China
The Center for Drug Evaluation (CDE) website has announced that Shenzhen Chipscreen Biosciences Co., Ltd’s...
Huadong Medicine’s Mirvetuximab Soravtansine Heads for Priority Review by China’s CDE
The China’s Center for Drug Evaluation (CDE) website has indicated that Huadong Medicine Co., Ltd...
RareStone Group’s Pitolisant Earns Priority Review Status for Narcolepsy Treatment in China
The Center for Drug Evaluation (CDE) website in China has indicated that RareStone Group, a...
LianBio’s Mavacamten Receives Priority Review Status from China’s CDE for oHCM Treatment
The Center for Drug Evaluation (CDE) has indicated on its website that China-based biotech firm...
Boehringer Ingelheim’s Spevigo on Track for Priority Review for GPP Flare Prevention in China
Germany-based Boehringer Ingelheim’s (BI) interleukin-36 receptor (IL-36R)-targeted orphan drug, Spevigo (spesolimab), in subcutaneous injection form,...