FDA News

Alabama Board of Medical Examiners Issues Warning on Non-FDA-Approved Peptides: What Pharma Teams Need to Know

FDA · 4 min

Vertex Announces FDA Acceptance of Biologics License Application for Accelerated Approval of Povetacicept in IgA Nephropathy

FDA · IgA Nephropathy · 4 min

Aurobindo Pharma OAI Classification: Implications for Drug Approvals

FDA · 5 min

Lee, Tuberville Introduce Protections for Homeopathic Medicine with FDA Approval Framework

FDA · 4 min

FDA Approves Ensitrelvir (XOCOVA) as First Oral Option for COVID-19 Post-Exposure Prophylaxis

FDA · COVID-19 · 5 min

FDA Priority Review Voucher Program: Will Makary's Initiative Survive?

FDA · 7 min

Texas AG Investigating Energy Drinks: What Pharma Teams Need to Know

FDA · 5 min

FDA Voucher Program Under Fire: Pharma and Patient Groups Demand Pause

FDA · 5 min

FDA Extends Comment Period for Real-Time Clinical Trials Pilot, AI Use in Studies

FDA · 6 min

FDA Approves Companion Diagnostic for Inavolisib in HR+/HER2–, PIK3CA-Mutated Breast Cancer

FDA · oncology · 5 min

The Peptide Reclassification Everyone's Talking About: A Pharmacist's Take on What RFK Jr's Announcement Actually Means — drug approvals

FDA · 5 min

Pharma Pulse: 340B Uncertainty, Drug Shortages, and Wegovy's Global Debut

FDA · 8 min