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...
Pediatric drugs
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...
Eisai’s Fycompa Gains New Indication for Generalized Tonic-Clonic Seizures in China
Eisai Co Ltd (TYO: 4523), a Japanese pharmaceutical company, has announced that its antiepilepsy drug...
Pfizer Pauses Dosing in DMD Gene Therapy Trial Following Participant’s Sudden Death
This week, Pfizer Inc. (NYSE: PFE) announced the unfortunate sudden death of a participant in...
Wanbangde Pharmaceutical’s Huperzine A Earns FDA Rare Pediatric Disease Designation for HIE Treatment
China’s Wanbangde New Building Materials Co., Ltd (SHE: 002082) has announced that its subsidiary, Wanbangde...
Novartis Receives Positive Interim Results for Antimalarial Coartem in Infants
Swiss pharmaceutical company Novartis (NYSE: NVS) has announced interim results from a Phase II/III clinical...
Novartis’s Lutathera Secures FDA Approval for Pediatric Gastroenteropancreatic NETs
The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS)...