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...
Priority reviews
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,...
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...