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...
Priority reviews
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,...
CDE Indicates Priority Review for Overland ADCT’s Zynlonta and BeiGene’s Brukinsa
The Center for Drug Evaluation (CDE) in China has indicated that Overland ADCT BioPharma (CY)...
Abbisko Therapeutics’ Pimicotinib Earns PRIME Status for TGCT from EMA
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that its Category 1 drug...
Novartis’s Iptacopan on Track for Priority Review Status in China for PNH Treatment
China’s Center for Drug Evaluation (CDE) website has indicated that Swiss pharmaceutical giant Novartis’ (NYSE:...
Chia Tai Tianqing’s TQ-B3525 Heads for Priority Review for Recurrent Follicular Lymphoma
The Center for Drug Evaluation (CDE) website has indicated that Chia Tai Tianqing’s TQ-B3525, a...
Roche’s Rozlytrek on Track for Priority Review for Pediatric NTRK Fusion Tumor Treatment
The Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Rozlytrek (entrectinib)...
CDE Lists Three Home-Grown Drugs for Priority Review, Including Myopia Treatment
The Center for Drug Evaluation (CDE) website has indicated that three home-grown drugs are on...
AstraZeneca’s Nirsevimab on Track for Priority Review for RSV Prevention in Infants
The Center for Drug Evaluation (CDE) website in China indicates that AstraZeneca’s (AZ, NASDAQ: AZN)...
Wuhan Institute’s Hexavalent Rotavirus Vaccine on Track for Priority Review by CDE
The Center for Drug Evaluation (CDE) website has indicated that Wuhan Institute of Biological Products...
Zai Lab’s Repotrectinib on Track for Priority Review by China’s CDE for ROS1+ NSCLC
The Center for Drug Evaluation (CDE) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB)...
Ocumension Therapeutics’ Zerviate Receives NMPA Priority Review for Ophthalmology Treatment
Ocumension Therapeutics (HKG: 1477), a leading Chinese ophthalmology specialist, has announced that its histamine H1...
Dizal Pharma Plans to Raise $376.1 Million for Drug R&D and Industrialization
Dizal (Jiangsu) Pharmaceutical Co., Ltd (SHA: 688192), the China-based joint venture established by AstraZeneca (AZ,...