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FDA

Clinical Trials Leucovorin Public Health Nonaddictive Pain Medication Market Reaction Inluriyo UZEDY (risperidone) Expedited Reviews Fast-Track Programs Leadership Issues Augmentin XR Safety Reviews Ethics Weight Loss Medications NEREUS™ Donanemab CNPV Program Kisunla

6 ARTICLES

last mo.

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

Internal documents show reviewers extended timelines after raising concerns over efficacy metrics, potential abuse risk, including a treatment-related death.

9 ARTICLES

2mo ago

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

10 ARTICLES

2mo ago

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

4 ARTICLES

2mo ago

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

3 ARTICLES

3mo ago

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

18 ARTICLES

4mo ago

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

8 ARTICLES

4mo ago

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

3 ARTICLES

4mo ago

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

4 ARTICLES

5mo ago

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

12 ARTICLES

5mo ago

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