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FDA Opens Early Access to KRAS-Targeting Pancreatic Cancer Pill After Strong Survival Data

An FDA early-access program has triggered heavy demand that is straining cancer centers.

FDA Grants Accelerated Approval to Avlayah for Neurologic Manifestations of Hunter Syndrome

FDA Delays Two Drugs in National Priority Voucher Program After Safety, Efficacy Flags

FDA Approves Vanda’s Nereus, First New Motion Sickness Treatment in Over 40 Years

FDA Opens Safety Review of Infant RSV Antibody Drugs Beyfortus and Enflonsia

FDA Fast-Tracks Augmentin XR in First Approval Under National Priority Voucher Pilot

Yale Study Finds Only 24% of Medicines Tested Reach Trial-Host Countries Within Five Years

FDA Drug-Review Chief George Tidmarsh Resigns as HHS Probes Conduct

FDA Names First 9 Drugs for ‘National Priority’ Fast-Track Reviews, Targeting 1–2-Month Decisions

FDA Clears Monthly Uzedy Injection for Maintenance Treatment of Bipolar I Disorder

Lilly Steps Up Obesity Push With San Diego Innovation Hub and $6.5 Billion Houston Factory

FDA Moves to List Leucovorin for Cerebral Folate Deficiency After White House Autism Promotion