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FDA

FDA Proposes Blocking Bulk Compounding of GLP-1 Drugs by Outsourcing Facilities

The move signals the agency sees no clinical need for bulk versions given improved supply.

ImmunityBio Files FDA Response on Anktiva Ads as Investor Suits Build

FDA Warns ImmunityBio Over Anktiva Ads, Citing Misleading Cancer Claims

FDA Biologics Chief Vinay Prasad to Step Down at End of April

FDA Installs Tracy Beth Hoeg as Acting CDER Director as Pazdur Files Retirement

FDA Names Richard Pazdur to Lead Drug Review Center

FDA to Remove Most Boxed Warnings From Menopause Hormone Therapies

FDA Class II Recall Targets 580,000 Prazosin Bottles for Nitrosamine Overages

FDA Posts More Than 100 Warning Letters in Drug Ad Crackdown, Targeting Hims, Lilly and Novo

Sarepta Temporarily Halts Elevidys Shipments Under FDA Request

FDA Names George Tidmarsh Director of Center for Drug Evaluation and Research