FDA Approves First Biosimilar to Treat Multiple Sclerosis
U.S. Food and Drug Administration
Tyruko® has been shown to safely mitigate and manage inflammation in autoimmune conditions like Crohn’s disease
Articles by U.S. Food and Drug Administration
FDA Approves First RSV Vaccine for Pregnant Individuals
U.S. Food and Drug Administration
According to the CDC, RSV is the leading cause of infant hospitalization in the US and warrants immediate preventive action
FDA Approves First Oral Treatment for Postpartum Depression
U.S. Food and Drug Administration
Multicenter clinical trials demonstrated the efficacy of Zurzuvae in women with PPD
FDA Approves New Drug to Prevent RSV in Babies, Toddlers
U.S. Food and Drug Administration
Beyfortus proved to be safe and efficacious in trials with infants at varying degrees of risk for RSV infection
FDA Approves First Gene Therapy for Adults with Severe Hemophilia A
U.S. Food and Drug Administration
Roctavian recipients should be closely monitored for infusion-related reactions and liver enzyme elevation
FDA Approves First Cellular Therapy for Type 1 Diabetes
U.S. Food and Drug Administration
Clinicians should consider the adverse effects when recommending Lantidra to patients
FDA Approves First Gene Therapy Treatment for Duchenne Muscular Dystrophy
U.S. Food and Drug Administration
About one in every 3,300 boys is affected by DMD and the current treatments don’t address the genetic cause
FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes
U.S. Food and Drug Administration
Jardiance, Synjardy were originally approved by the FDA in 2014 and 2015 respectively to improve blood sugar control in adults with T2D
FDA Pilot Reduces Risks Linked to Lab-Developed Tests in Cancer Diagnostics
U.S. Food and Drug Administration
Program aims to facilitate consistent performance of in vitro diagnostic tests, better oncology drug selection, and improved patient care
FDA Announces Additional Steps to Modernize Clinical Trials
U.S. Food and Drug Administration
Digital health technologies could facilitate agile data collection and improve regulatory decision-making