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Drug Approval Process

Biologics License Application Clinical Trials Quality Control Counterfeit Drug Enforcement Drug Shortage Management Elevidys Clinical Holds Voluntary Hold Agency Oversight New Drug Application MDMA Therapy Orforglipron Approval

Lilly’s Daily Obesity Pill Sustains Weight Loss After Switch From Wegovy or Zepbound

FDA could issue a U.S. decision by March 28 under a faster review timeline, according to Reuters.

FDA Setback Puts uniQure’s Huntington’s Gene Therapy Filing in Doubt

FDA Accepts Replimune’s Resubmitted RP1 Melanoma Filing, Sets April 2026 Decision