FDA News

FDA Breakthrough Therapy Designations: Impact on Neurological Disorder Investments 2026

FDA · neurological disorders · 11 min

Pembrolizumab KEYNOTE-826 Trial: Expanded Use in Advanced Cervical Cancer

FDA · oncology · 9 min

FDA Approval KRAS G12C NSCLC: Sotorasib & Adagrasib Insights

FDA · oncology · 10 min

FDA Approval mRNA Vaccine RSV: Market Impact & Future Outlook

FDA · Infectious Diseases · 4 min

BrioHealth Solutions Receives FDA Conditional Approval for Pediatric BrioVAD Heart Device Trial

FDA · 2 min

FDA Accelerated Approval of KRAS G12C Inhibitors in NSCLC: Sotorasib vs Adagrasib

FDA · oncology · 11 min

FDA Approves Regeneron's Otarmeni: First Gene Therapy for Genetic Hearing Loss Shows 80% Success Rate

FDA · Genetic Hearing Loss · 4 min

FDA Guidance on Accelerated Approval: Key Updates for Oncology Drugs

FDA · Oncology · 12 min

Pediatric Clinical Trials: FDA's Updated Requirements and Incentives

FDA · Pediatrics · 4 min

FDA Guidance on Oncology Drugs: Impact on Accelerated Approval Pathways

FDA · Oncology · 13 min

FDA Real-World Evidence: Evolving Regulatory Framework and Market Impact

FDA · Medical Devices · 9 min

Clinical Trial Protocol Amendments: FDA Insights on Timeline & Cost Impact

FDA · Clinical Development · 4 min