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

FDA Rejects Replimune’s Melanoma Virus Therapy Again for Insufficient Evidence

The decision underscores the FDA’s insistence on well‑controlled efficacy data over single‑arm results.

FDA Flags Recall of 3.1 Million Store-Brand Eye Drops Over Sterility Concerns

3.1 Million Bottles of Store-Brand Eye Drops Recalled for Sterility Concerns

Pfizer and BioNTech Halt U.S. COVID Vaccine Trial for 50–64-Year-Olds Over Slow Enrollment

FDA Flags 76 Liver Injuries Linked to Amgen’s Tavneos, Urges Tight Monitoring

FDA Approves Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

FDA Grants Accelerated Approval to Avlayah for Neurologic Manifestations of Hunter Syndrome

Pfizer, Valneva Seek Approval for Lyme Vaccine After >70% Efficacy in Phase 3

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

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