CDE Releases Draft Guidelines for Extrapolating Adult Drug Data to Pediatric Use
The Center for Drug Evaluation (CDE) has released the “Guidelines on Quantitative Methodology for Extrapolating...
Pediatric drugs
Pfizer’s Zavicefta Approved in China for Pediatric Complex Intra-Abdominal Infections
US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced that it has received market approval from...
Ark Biosciences’ Ziresovir Shows Positive Results in Phase III AIRFLO Study for RSV Infection
China-headquartered Ark Biosciences has announced positive results from the Phase III AIRFLO study for its...
Fosun Pharma Launches 20ml SPSB Liquid Product in US Market
Shanghai Fosun Pharma (Group) Co., Ltd (SHA: 600196, HKG: 2196) has reported the market launch...
Tris Pharma and Pediatrix Therapeutics’ ADHD Drug Gains Priority Review in China
The Center for Drug Evaluation (CDE) has indicated that the methylphenidate hydrochloride oral sustained-release dry...
Humanwell’s Generic Clobazam Approved for Lennox-Gastaut Syndrome in China
China-based Yichang Humanwell Pharmaceutical Co., Ltd’s generic version of Sanofi’s clobazam (trade name: Frisium) has...
Lee’s Pharma Expands Global Rights to Windtree’s KL4 Surfactant Products
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has expanded its licensing agreement with US-based Windtree...
Wanbangde Pharmaceutical to Acquire Consun Pharma Shares in RMB 2.2B Deal
China-based Wanbangde Pharmaceutical Group has entered into a non-legally binding letter of intent with Consun...
Tris Pharma and Pediatrix’s Methylphenidate Tablet, Ipsen’s Triptorelin Injection Awarded Priority Review by CDE
The Center for Drug Evaluation (CDE) website shows that US-based Tris Pharma and Pediatrix Therapeutics’...
Eli Lilly’s Retevmo Wins Special Approval in China’s Lecheng Medical Pilot Zone
Eli Lilly & Co. (NYSE: LLY) has secured special approval for its RET kinase inhibitor...
China’s 2021 Healthcare Report Shows Rising Life Expectancy, Increased Medical Spending
China’s National Health Commission (NHC) released the “Healthcare Statistical Communique 2021,” revealing increased healthcare spending,...
Hrain Biotech and Novartis Receive Breakthrough Therapy Designations for CAR-T and Zolgensma
The Center for Drug Evaluation (CDE) website indicates that Hrain Biotechnology Co., Ltd’s BCMA –...
PersonGen BioTherapeutics’ TAA06 Receives Clinical Trial Approval for B7-H3 CAR-T Therapy
The Center for Drug Evaluation (CDE) website indicates that PersonGen BioTherapeutics (Suzhou) Co., Ltd’s TAA06,...
Sobi’s Anakinra (Kineret) Prioritized for Review in China for FMF Treatment
The Center for Drug Evaluation (CDE) website indicates that Swedish Orphan Biovitrum AB’s (Sobi; BMV:...
NHC Releases Technical Guidelines for Drug Clinical Evaluation
The National Health Commission (NHC) has released the “Technical Guidelines for Comprehensive Clinical Evaluation of...
Walvax Biotechnology Halts EV71 Vaccine Development Amid Changing Disease Trends
China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the decision to terminate a clinical...
NHSA Releases Draft Proposals for NRDL Annual Renewal Process
The National Healthcare Security Administration (NHSA) has formulated and released draft proposals for rules covering...
Bayer Initiates US Recall of TRK Inhibitor Vitrakvi Due to Mold Contamination
Germany-based Bayer (ETR: BAYN) has announced a voluntary recall of a specific lot of its...