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Honey Energy Supplement Recalled After FDA Finds Undeclared ED Drug

Regulators say testing found undisclosed tadalafil, posing risks to users on nitrate medications.

FDA Grants Breakthrough Therapy Designation to Biogen’s Litifilimab for Cutaneous Lupus

Merck Ends Revolution Medicines Takeover Talks After Valuation Standoff

Valneva Pulls U.S. Filings for Chikungunya Vaccine as FDA Halts Trials Over Safety Review

FDA Delays Two Drugs in National Priority Voucher Program After Safety, Efficacy Flags

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

FDA Issues Second Rejection of Atara’s EBV+ PTLD Therapy Tabelecleucel

FDA Grants Priority Review to Axsome’s AXS-05 for Alzheimer’s Agitation, Sets April 30 PDUFA Date

MediNatura Recalls All ReBoost and ClearLife Nasal Sprays Over Contamination Risk

FDA Clears Enhertu-Perjeta Combo for First-Line HER2-Positive Metastatic Breast Cancer

Sanofi Ends PPMS Bid After Tolebrutinib Fails Phase 3 as FDA Delays Review for nrSPMS

FDA Reportedly Weighing Black Box Warning for COVID-19 Vaccines

MediNatura Recalls ReBoost Nasal Spray Lot Over Mold and Bacterial Contamination

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

FDA Class III Recall Targets 11,136 Bottles of Ziac Over Trace Ezetimibe Contamination

FDA Meeting Minutes Undercut uniQure’s Plan to File Huntington’s Gene Therapy for Approval

FDA Accepts Sonrotoclax NDA, Grants Priority Review for Relapsed Mantle Cell Lymphoma

Nuvalent Reports 31% ORR in Pretreated, 86% in Untreated ALK+ NSCLC With Neladalkib

FDA Adds Boxed Liver Warning and Limits Elevidys to Ambulatory Boys 4 and Up

FDA Drops Broad Black-Box Warnings on Menopause Hormone Therapy