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Sarepta Defies FDA, Keeps Duchenne Gene Therapy on the Market

Regulators have placed limb-girdle muscular dystrophy trials on hold to assess Elevidys’s safety after three liver-failure deaths.

FDA Advisers Recommend Against Approval of GSK’s Myeloma Drug Blenrep

FDA Approves Prefilled Syringe Format for GSK’s Shingrix Vaccine

AstraZeneca’s Baxdrostat Delivers Significant Blood Pressure Reductions in Phase 3 Trial for Resistant Hypertension

ProKidney Shares Climb Over 700% Ahead of FDA Meeting

UK Regulator Probes Pancreatitis Cases Tied to GLP-1 Weight-Loss Therapies

Ambroxol Demonstrates Safety and Neuroprotection Signals in Parkinson’s Dementia Trial

Study Finds One in Six Cancer Medications in Sub-Saharan Africa Defective

Cidara’s CD388 Antiviral Achieves Up to 76% Flu Protection in Phase 2b Trial

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

NICE Poised to Reject NHS Coverage for Breakthrough Alzheimer’s Drugs

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