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Drug Approval

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ImmunityBio Sets 30-Day FDA Submission After Positive Meeting on Anktiva Expansion

Published long-term outcomes alongside rising revenue strengthen the case for a papillary NMIBC label.

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

FDA Seeks Removal of Suicide Warnings From Saxenda, Wegovy and Zepbound

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

RFK Jr. Overhauls HHS With Deep Cuts, MAHA Push and Vaccine Policy Reversals

FDA Expands Addyi Use to Postmenopausal Women, Including Those Over 65

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 Approves Palsonify, First Once-Daily Oral Treatment for Acromegaly

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

EU Panel Backs Tezspire for Chronic Rhinosinusitis With Nasal Polyps

Savara Investors Pressed to Seek Lead Role in Securities Suit Before Nov. 7 Deadline

FDA to Publicly Release All Future Drug Rejection Letters, Posts 89 Recent CRLs

GLP-1 Agonists Tied to Higher Risk of Macular Degeneration and Rare Optic Neuropathy