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...
Pediatric drugs
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...
Day One Biopharmaceuticals Expands Pipeline with MabCare Therapeutics Licensing Deal
Day One Biopharmaceuticals (NASDAQ: DAWN), a California-based biotech company that recently celebrated its first drug...
Amgen’s Blincyto Secures New Indication Approval for B-ALL Consolidation Treatment in the US
Amgen (NASDAQ: AMGN) has announced that its bispecific T-cell engager (BiTE) Blincyto (blinatumomab) has received...
Pfizer’s Gene Therapy for Duchenne Muscular Dystrophy Misses Late-Stage Trial Endpoints
Pfizer Inc. (NYSE: PFE) has announced that a late-stage clinical trial for its investigational gene...
AstraZeneca’s Farxiga Receives FDA Approval for Pediatric Type-2 Diabetes Treatment
The US Food and Drug Administration (FDA) has granted regulatory approval to AstraZeneca (AZ; NASDAQ:...
RareStone Group’s Pitolisant Secures NMPA Approval to Treat Narcolepsy in Children and Adolescents
RareStone Group, a China-based company specializing in rare diseases (formerly known as Citrine Medicine), has...