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...
Pediatric drugs
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)...
China’s CDE Issues Guidelines for Pediatric Drug Labeling Updates
China’s Center for Drug Evaluation (CDE) has issued a notice outlining the “Detailed Rules for...
AstraZeneca’s Fasenra Gains FDA Approval for Pediatric Severe Asthma Treatment
AstraZeneca (AZ; NASDAQ: AZN) has secured an indication extension from the U.S. Food and Drug...
Shanghai’s 9th People’s Hospital Launches Groundbreaking Gene Therapy Trial for Congenital Deafness
In a medical first, Shanghai’s 9th People’s Hospital has initiated the world’s inaugural clinical trial...
GSK’s ViiV Healthcare Expands Dovato Indication to Include Adolescents with HIV-1 Infection
GlaxoSmithKline’s (GSK; NYSE: GSK) ViiV Healthcare has received an indication extension from the US Food...
European Commission Approves Pfizer’s Prevenar 20 for Pediatric Use
The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its 20-valent...
Amgen Reports Positive Results for Otezla in Pediatric Psoriasis Trial
Amgen (NASDAQ: AMGN) provided an update last week on a late-stage trial evaluating its PDE4...
China Aims to Insure 80% of Newborns with Basic Medical Insurance by 2024
The National Healthcare Security Administration (NHSA) and the National Health Commission (NHC), along with three...
Novartis Gene Therapy Zolgensma Shows Continued Benefits in Broader SMA Patient Group
Swiss pharmaceutical giant Novartis (NYSE: NVS) has presented Phase III data this week, demonstrating that...
Hainan Poly Pharm Secures Tentative FDA Approval for Generic Version of UCB’s Briviact
Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it...
FDA Approves Takeda’s Eohilia as First Oral Therapy for Eosinophilic Esophagitis in Patients Aged 11 and Up
The U.S. Food and Drug Administration (FDA) has granted approval to Takeda Pharmaceutical Company (TYO:...