Servier’s Vorasidenib Enters China’s SPARK Program – First Dual IDH Inhibitor for IDH‑Mutant Glioma
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) issued a...
Pediatric drugs
FDA Issues Boxed Warning on Elevidys (delandistrogene moxeparvovec‑rokl) – Use Limited to Ambulatory DMD Patients Aged 4+
The U.S. Food and Drug Administration (FDA) announced a Boxed Warning for Elevidys, Sarepta Therapeutics’...
Novartis Asciminib Enters China’s SPARK Program for Pediatric Chronic Myeloid Leukemia
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced today...
Grand Pharma Launches GPN00884 Clinical Trial to Tackle Pediatric Myopia Progression
Grand Pharmaceutical Group Limited (HKG: 0512), a China-based company, announced on October 26, 2025, that...
Bioheng Therapeutics Receives FDA RPDD for Off‑The‑Shelf CAR‑T CTD402
Bioheng Therapeutics (China) announced that the U.S. Food and Drug Administration (FDA) has granted Rare...
Sobi North America’s Doptelet Approved by FDA for Pediatric ITP Treatment
Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi), announced today...
Jiangsu Vcare PharmaTech’s VC004 NDA Accepted for Review by China’s NMPA
China-based Jiangsu Vcare PharmaTech Co., Ltd announced that its New Drug Application (NDA) for VC004...
Merck’s Prevymis Approved in China for Pediatric CMV Prevention
US-based pharmaceutical giant Merck, Sharp & Dohme (MSD, NYSE: MRK) announced that its novel non-nucleoside...
Merck Q1 2025 Results: Keytruda Sales Grow 6% Despite Gardasil Dip in China
Global pharmaceutical company Merck (NYSE: MRK) released its Q1 2025 financial results, showing total sales...
Novo Nordisk’s Sogroya Approved for Use in Boao Lecheng Medical Zone
Denmark-based Novo Nordisk (NYSE: NVO) has announced that its long-acting somatotropin Sogroya (somapacitan) has been...
CDE Launches SPARK Project to Boost Pediatric Antitumor Drug R&D
China’s Center for Drug Evaluation (CDE) has released a notification to solicit feedback on its...
Jointown Pharmaceutical Partners with Shandong DYNE to Boost Pediatric Drug Distribution
Jointown Pharmaceutical Group Co., Ltd (SHA: 600998), China’s largest private pharmaceutical distributor, has partnered with...
Zhaoke Ophthalmology’s NVK002 ANDA Accepted for Review by China’s NMPA
China-based Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has...
Johnson & Johnson Submits sBLA to FDA for Simponi in Pediatric Ulcerative Colitis
US pharmaceutical major Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of a...
Johnson & Johnson MedTech’s Impella Heart Pumps Gain FDA Approval for Pediatric Heart Failure
US major Johnson & Johnson MedTechhas announced receiving premarket approval (PMA) from the US Food...
MSD’s Noxafil Receives NMPA Approval for Pediatric Use in Antifungal Treatment
US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced that China’s National Medical...
Yunnan Province Increases Pediatric Medical Service Prices for Children Under 6
The Yunnan Provincial Healthcare Security Administration and the Health Commission of Yunnan Province have issued...
NHC Releases Updated List of Pediatric Drugs for Research and Development Incentives
The National Health Commission (NHC) has issued a notification regarding the fifth batch of pediatric...
Takeda Prepares to File Dengue Fever Vaccine for US Approval, Expanding Global Regulatory Reach
Takeda Pharmaceutical, a leading Japanese pharmaceutical company listed on the NYSE (NYSE: TAK), is reportedly...
Servier’s Voranigo Receives FDA Nod for IDH Inhibitor as Brain Tumor Treatment
The U.S. Food and Drug Administration (FDA) has granted first-time approval for Voranigo (vorasidenib), a...