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FDA Issues Draft Guidance Easing Primate Tests for Some Antibody Drugs

Public comment will determine the proposal's path to adoption.

Missouri, Kansas and Idaho Sue to Block FDA’s New Generic Mifepristone Approval, Curb Mail-Order Access

FDA Adds Boxed Warning to Elevidys, Narrows Use to Ambulatory Patients 4 and Older

Kenvue Asks FDA to Reject Autism Warning on Tylenol in Pregnancy

FDA Rejects Replimune’s RP1 Melanoma Immunotherapy

FDA and A.P. Deauville Recall Over 67,000 Cases of Power Stick Roll-On Deodorant

FDA and A. P. Deauville Recall Over 67,000 Power Stick Roll-On Deodorants

FDA Approves Gardenia Blue, Urges Accelerated Red No. 3 Phase-Out

FDA Ends GLP-1 Drug Shortages, Triggering New Pricing and Coverage Moves