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FDA Approves Leucovorin for Ultra-Rare FOLR1 Folate Disorder, Declines Autism Indication

The decision follows an agency review that judged the autism evidence insufficient.

FDA Proposes ‘Plausible Mechanism’ Pathway for Individualized Rare-Disease Therapies

HHS Launches Cellphone Radiation Study as FDA Pulls Old Safety Webpages

FDA Eases Oversight of Wearables and Clinical Decision Support in Final Guidance

FDA Expands Review of Possible COVID Vaccine-Linked Deaths to Multiple Age Groups

Former FDA Chiefs Rebuke Leaked Memo Claiming COVID Shots Killed 10 Children, Warn of Risky Vaccine Overhaul

FDA Names Tracy Beth Høeg Acting CDER Director as OTC Drugs Chief Is Reassigned

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

FDA Publishes Draft Guidance for Non-Opioid Analgesics to Treat Chronic Pain

FDA Weighs Ending Pfizer COVID-19 Authorization for Children Under 5

Vinay Prasad Resigns as FDA Biologics Director After Politicized Tenure

US Stops Recommending COVID-19 Shots for Healthy Kids and Pregnant Women

Moderna Withdraws Flu-COVID Vaccine Application After FDA Requests More Data

Report Finds 75% of U.S. Sunscreens Fall Short on Safety and Effectiveness

FDA Grants Limited Approval to Novavax’s COVID-19 Vaccine

FDA Moves to Remove Ingestible Fluoride Products for Children Over Safety Concerns