FDA News

FDA Accepts Genentech's Gazyva Application for Systemic Lupus Erythematosus Treatment

FDA · 2 min

FDA Continuous Manufacturing: Key Insights on Drug Quality & Supply Chain

FDA · 10 min

FDA Real-World Evidence: Transforming US Drug Development Strategies

FDA · General drug development · 10 min

Diversity in Clinical Trials: FDA's New Guidance and Early Impact

FDA · Clinical Trials · 10 min

Breakthrough Therapy Designations Drive Neurological Drug Innovation in US

FDA · neurological disorders · 4 min

Clinical Trial Cost Analysis 2024: FDA Insights on Phase 1-3 Expenses

FDA · Oncology · 10 min

Biosimilar Competition Impact: US Biologics Market Analysis 2026

FDA · Oncology · 13 min

FDA Approves RGEN-101: RareGen’s Orphan Drug for Genetic Disorder

FDA · Rare Genetic Disorders · 7 min

FDA Approves Inflammex: Novel Biologic for Ulcerative Colitis

FDA · Ulcerative Colitis · 7 min

FDA Approves Synapton: Breakthrough for Severe Alzheimer's Treatment

FDA · Alzheimer's disease · 5 min

FDA Approves Generic EpiPen: Key Details on Mylan’s Price Solution

FDA · allergy · 3 min

Xodus Medical Receives FDA 510(K) Clearance for Hot Pink Pad Surgical Temperature Management System

FDA · 2 min