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...
Pediatric drugs
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:...
Dupixent by Sanofi and Regeneron Approved by FDA for Eosinophilic Esophagitis in Younger Pediatric Patients
The US Food and Drug Administration (FDA) has concluded a priority review and granted approval...
Eli Lilly’s Subsidiary Akouos Reports Positive Preliminary Results for Gene Therapy in Hearing Loss
Eli Lilly (NYSE: LLY) has announced preliminary results from a Phase I/II study conducted by...
Drug Farm’s DF-003 Earns FDA Rare Pediatric Disease Designation for ROSAH Syndrome
Sino-US biotech company Drug Farm has announced that it has received Rare Pediatric Disease Designation...
China’s NHC Unveils Strategy to Enhance Pediatric Healthcare by 2025
The National Health Commission (NHC) has issued a set of Opinions aimed at “Promoting the...
Thederma’s TAP-1503 Cream Receives Priority Review Status for Pediatric Atopic Dermatitis Treatment in China
The Center for Drug Evaluation (CDE) website has indicated that China-based Thederma’s TAP-1503 cream is...
EMA’s CHMP Gives Green Light to Sanofi’s Fexinidazole for Acute Sleeping Sickness Treatment
Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...
Vertex Pharmaceuticals and CRISPR Therapeutics Receive Conditional Approval for CRISPR Gene-Editing Therapy
Vertex Pharmaceuticals (NASDAQ: VRTX) and CRISPR Therapeutics (NASDAQ: CRSP) have received conditional approval from the...
Roche’s Gene Therapy Elevidys Misses Primary Endpoint in DMD Trial
Switzerland-headquartered pharmaceutical giant Roche (SWX: ROG) has announced that a Phase III trial for its...
Pfizer’s Penbraya Receives FDA Approval for Meningococcal Immunization
Pfizer Inc. (NYSE: PFE) announced last week that it has successfully registered its pentavalent meningococcal...
Bayer Partners with HALO Precision Diagnostics to Develop Gadoquatrane for MRI Applications
Germany-based Bayer (ETR: BAYN) has announced a strategic partnership with US radiology expert HALO Precision...