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Pfizer and BioNTech Halt U.S. COVID Vaccine Trial for 50–64-Year-Olds Over Slow Enrollment

Tougher FDA rules are squeezing efforts to test shots in healthy adults 50 to 64.

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

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

FDA Clears Second Generic Mifepristone as White House Cites Legal Duty

FDA Clears Signos’ AI CGM for Weight Management as OTC Service Launches

OTC Birth Control Tied to Major Uptake Gains in First Year, National Study Finds

FDA Hears Final Testimony on Removing Prescription Fluoride Supplements

More Than 10 Major Food Companies Pledge to Phase Out Synthetic Dyes

FDA Expands Myocarditis and Pericarditis Warnings on mRNA COVID-19 Vaccines

FDA launches AI assistant Elsa early as staff flag readiness issues

FDA Approves Moderna’s mNEXSPIKE for Seniors and High-Risk Adults as CDC Drops Recommendations for Healthy Children and Pregnant Women