FDA News

FDA Accepts Praxis Precision Medicines' New Drug Application for Ulixacaltamide HCl Essential Tremor Treatment

FDA · 2 min

FDA Approves FILSPARI (Sparsentan) for FSGS: First Treatment for Rare Kidney Disease

FDA · Nephrology - Focal Segmental Glomerulosclerosis (FSGS) · 4 min

FDA Approves LumaGen Gene Therapy for Inherited Retinal Disease

FDA · Inherited Retinal Disease · 8 min

FDA Approves Biosimilar Insulin Lispro: What You Need to Know

FDA · Diabetes Mellitus · 4 min

FDA Approves OsteoBuild: New Bone-Building Agent for Severe Osteoporosis

FDA · Osteoporosis · 5 min

FDA Priority Review Granted to PharmaGiant's CholesterolRx for High Cholesterol

FDA · Cardiovascular · 6 min

Telemedicine Pharmaceutical Access: What You Need to Know (FDA Insights)

FDA · Chronic Disease Management · 11 min

FDA Approves SomniRestore: New Chronic Insomnia Treatment

FDA · Chronic Insomnia · 6 min

FDA Approves LysoClear: New Treatment for Lysosomal Storage Disorders

FDA · Lysosomal Storage Disorders · 7 min

FDA Launches Manufacturing PreCheck Pilot Program to Streamline Drug Production Oversight

FDA · 2 min

Real-World Evidence Transforms Drug Development as FDA Expands Regulatory Framework

FDA · 2 min

FDA Releases Updated Database of Untitled Letters for Pharmaceutical Marketing Violations

FDA · 2 min