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Regulatory Agencies

FDA MHRA European Medicines Agency AEMPS ANSM Drug Approval Process Drug Approval NHS Yellow Card Scheme Health Canada

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

The release aims to demystify the FDA’s review process through transparent feedback redacted for confidentiality.

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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

EMA Confirms Very Rare Vision Loss Risk Linked to Semaglutide

MHRA Recalls Two Batches of Prescription Paracetamol for Potential Contamination

UK Regulators Warn Weight-Loss Injections Could Undermine Birth Control

MHRA Warns Women on Ozempic, Mounjaro and Wegovy to Use Effective Contraception After Pregnancy Reports

Health Canada Recalls Teva Seasonale Birth Control Over Extra Placebo Pills

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

Spain Orders Withdrawal of Injected Cosmetic Products Containing Hyaluronidase

FDA Audit Triggers Nationwide Recall of Over 75,000 Eye Care Products

Over 32,000 Boxes of Lisinopril Recalled in France Over Labeling Error

NHS England to Introduce Europe’s First Injectable Cancer Immunotherapy

UK Grants First Global Approval for GSK’s Blenrep in Two Combination Therapies

EU Regulators Reject Eli Lilly's Alzheimer's Drug Over Safety Concerns

FDA Recalls Acne Products Over Benzene Contamination Concerns

EU Drug Agency Recommends Approval of First Alzheimer’s Treatment Targeting Disease Progression

NHS England Faces Concerns Over MS Drug Switch After Reports of Severe Side Effects