FDA News

ImmunityBio's Anktiva Expansion: Navigating FDA Decision Dates and Regulatory Hurdles

FDA · bladder cancer · 9 min

UCB's Bimzelx vs. AbbVie's Skyrizi: Psoriatic Arthritis Competitive Landscape

FDA · psoriatic arthritis · 8 min

SERB Pharmaceuticals Acquires European and MENA Rights to Idefirix® (imlifidase) from Hansa Biopharma AB

FDA · 6 min

FDA Approves Baxdrostat (Baxfendy) as First Aldosterone Synthase Inhibitor for Uncontrolled Hypertension

FDA · hypertension · 7 min

Eisai's Leqembi Sales Forecast: Projecting Blockbuster Status in Alzheimer's

FDA · Alzheimer's · 6 min

Italy's Clinical Research Landscape: Strengths, Weaknesses, and Strategic Implications

FDA · 7 min

FDA Delays AstraZeneca's Breast Cancer Drug Review: Key Insights

FDA · breast cancer · 2 min

Actinogen's EMA Scientific Advice: A Positive Step for Alzheimer's Program

FDA · Alzheimer's disease · 2 min

Navigating the 2026 Cell Therapy Regulatory Landscape

FDA · cell therapy · 2 min

Imfinzi Receives FDA Approval for Bladder Cancer Treatment

FDA · oncology · 2 min

Imfinzi Approved for Unique Bladder Cancer Combo: A Game Changer

FDA · oncology · 2 min

Viridian Partners with WuXi Bio for Eye Drug Supply Amid FDA Decision

FDA · 4 min