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FDA Recalls Specific FreeStyle Libre 3 Sensors Over Faulty Low-Glucose Readings

Regulators specified the affected Libre 3 sensors following reports of falsely low readings linked to serious harm.

FDA Seeks Removal of Suicide Warnings From Saxenda, Wegovy and Zepbound

MediNatura Recalls All ReBoost and ClearLife Nasal Sprays Over Contamination Risk

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

Walgreens Recalls Saline Nasal Spray After FDA Flags Bacterial Contamination

FDA Drops Broad Black-Box Warnings on Menopause Hormone Therapy

FDA Issues Warning Letters to 18 Websites Selling Unapproved Botox-Like Injectables

FDA Issues Safety Alert on RF Microneedling Injuries

Teva, Amerisource Pull 580,000+ Prazosin Bottles as FDA Flags Nitrosamine Contamination

Ascend Recalls 141,984 Bottles of Generic Atorvastatin Over Dissolution Failures

FDA Signals Openness to Accelerated Path for Lexeo’s Friedreich’s Ataxia Cardiac Gene Therapy

FDA Approves Palsonify, First Once-Daily Oral Treatment for Acromegaly

FDA Approves Brensocatib as First Treatment for Non-Cystic Fibrosis Bronchiectasis

HHS Removes Thimerosal From All U.S. Flu Vaccines Ahead of 2025-26 Season

FDA Begins Expert Review of Menopause Hormone Therapy Warnings

FDA Publishes Over 200 Complete Response Letters for 2020–24 Drug Applications

FDA Restricts Moderna and Novavax COVID-19 Vaccines to Seniors and Vulnerable Groups

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

Medtech Products Recalls Children's Honey Cough Syrup Over Bacterial Contamination

FDA Introduces Elsa AI to Fast-Track Drug and Device Approvals