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FDA

Drug Approval Process Vaccine Approval Process Drug Safety Biologics License Application Drug Approval Drug Recalls New Drug Application Drug Approval Processes Product Recalls Breakthrough Therapy Designation

FDA Approves Nivolumab Plus AVD as First-Line Therapy for Advanced Hodgkin Lymphoma

The decision follows a head-to-head phase 3 trial that showed a marked progression-free survival advantage over brentuximab vedotin plus AVD.

For Third Time, FDA Rejects Aldeyra’s Dry-Eye Drug Reproxalap Over Efficacy

FDA Expands GSK’s Arexvy to High-Risk Adults 18–49, Completing Trio of RSV Vaccines for Younger At‑Risk Group

FDA Advisers Back 2026–27 Flu Shot Overhaul to Target Dominant H3N2 Variant

FDA Warns Novo Nordisk Over Missed Reporting of Serious Semaglutide and GLP-1 Adverse Events

FDA Proposes ‘Plausible Mechanism’ Pathway for Individualized Rare-Disease Therapies

FDA Rejects Filing of Moderna’s mRNA Flu Vaccine Over Comparator Dispute

FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy Application

Honey Energy Supplement Recalled After FDA Finds Undeclared ED Drug

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