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)...
Priority reviews
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,...
LianBio Appoints Pascal Qian as COO in Anticipation of Mavacamten Market Launch
China-based biotech firm LianBio (OTCMKTS: LIANY) has announced the promotion of its current China General...
Takeda Pharma’s Iclusig Poised for Priority Review by CDE for Leukemia Treatments
The Center for Drug Evaluation (CDE) website has indicated that Takeda Pharma’s (TYO: 4502) Iclusig...
Luye Pharma’s Lurbinectedin Gains Priority Review Status for SCLC Treatment
The Center for Drug Evaluation (CDE) website indicates that China-based Luye Pharma Group’s (HKG: 2186)...
Hengrui Pharmaceuticals’ Dexmedetomidine Nasal Spray Approved by NMPA
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received marketing...
Sanofi’s Dupixent Receives Priority Review for Prurigo Nodosa Treatment
French pharmaceutical major Sanofi (NASDAQ: SNY) has announced that it has received priority review status...
CDE Signals Priority Review for Sanofi’s Dupixent and Other Drugs
The Center for Drug Evaluation (CDE) website indicates that France major Sanofi’s (NASDAQ: SNY) Dupixent...
CDE Awards Priority Review to Eisai’s Lecanemab for Early Alzheimer’s Disease
The Center for Drug Evaluation (CDE) website indicates that Japan-based Eisai’s (TYO: 4523) lecanemab has...
SciClone Pharmaceuticals Files for Hong Kong Market Approval of Danyelza
SciClone Pharmaceuticals Inc. (Nasdaq: SCLN), which became a China-based company after going private in 2017,...
CDE Grants Priority Review Status to Kechow’s HL-085 for Melanoma Treatment
The Center for Drug Evaluation (CDE) website indicates that Kechow Pharma’s HL-085 is set to...
CDE Grants Priority Review to Takeda’s Vonicog Alfa, Zhongmei’s Rilonacept, and Zai Lab’s SUL-DUR
The Center for Drug Evaluation (CDE) has indicated that Takeda’s Vonicog alfa, Zhongmei Huadong Pharma’s...
Roche’s Glofitamab and Dizal’s Sunvozertinib Enter Priority Review
The Center for Drug Evaluation (CDE) website indicates that Swiss giant Roche’s (SWX: ROG) glofitamab...
Everest Medicines’ Nefecon Receives Priority Review Recommendation from CDE
China-based Everest Medicines (HKG: 1952) has announced that the Center for Drug Evaluation (CDE) of...
NMPA Approves Viatris’ Symfi Lo for HIV-1 Treatment in China
The National Medical Products Administration (NMPA) website indicates that US-based Viatris Inc.’s (NASDAQ: VTRS) Symfi...
Hengrui’s Pyrotinib Granted Priority Review for HER2-Positive Breast Cancer
The Center for Drug Evaluation (CDE) website has announced that China-based Hengrui Pharmaceuticals’ (SHA: 600276)...
CDE Prioritizes Review for Jiedi Pharma’s Mitotane and Other Key Drugs
The Center for Drug Evaluation (CDE) website indicates that market filings for several key drugs,...
Innovent’s Parsaclisib Filed for Marketing Approval in China
China’s Center for Drug Evaluation (CDE) has received a marketing approval application for Innovent Biologics...
ScienCare Pharma’s Naltrexone Implant Prioritized for Review by CDE
The Center for Drug Evaluation (CDE) website indicates that the market filing by China-based Shenzhen...