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Sarepta Halts Elevidys Shipments for Non-Ambulatory Patients After Second Fatal Liver Failure

Sarepta is enlisting experts to design a stronger immunosuppressive regimen.

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

FDA Approves Merck’s Enflonsia Monoclonal Antibody for Infant RSV Prevention

GLP-1 Agonists Tied to Higher Risk of Macular Degeneration and Rare Optic Neuropathy

FDA launches AI assistant Elsa early as staff flag readiness issues

FDA Authorizes CLAIRITY BREAST AI for Personalized Five-Year Breast Cancer Risk Prediction

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

FDA Expands Myocarditis Warnings for COVID-19 Vaccines Amid Senate Scrutiny

Trump Administration Begins Enforcing Prescription Drug Price Controls

FDA Approves First Blood Test for Alzheimer’s Diagnosis

Moderna Withdraws Flu-COVID Vaccine Application After FDA Requests More Data

FDA Approves First Blood Test for Early Alzheimer’s Diagnosis in Symptomatic Adults

FDA Grants Limited Approval to Novavax’s COVID-19 Vaccine

FDA Approves First Blood Test for Alzheimer’s Diagnosis

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

Nationwide Recall of Eye Care Products Over Sterility Concerns

FDA Reviews Pembrolizumab for Transformative Head and Neck Cancer Treatment

New Drug Delivery Strategy Could Transform Cancer and Neurological Treatments

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

Leqembi Approved by European Regulators for Early-Stage Alzheimer's Treatment