FDA News

FDA Delays Ruling on AstraZeneca’s Breast Cancer Drug: Implications for Pharma

FDA · breast cancer · 2 min

Gilead's Hepcludex Secures FDA Approval: Implications for Pharma

FDA · hepatitis · 3 min

FDA vs EMA: The Camizestrant Controversy

FDA · oncology · 2 min

Astellas Cuts Costs Amid FDA Review of Moderna Vaccine

FDA · 3 min

Mirum Maps FDA Path After Anti-Itch Candidate Scores Phase 2 Win

FDA · oncology · 3 min

Praise for FDA’s Acting Commissioner: Implications for Pharma

FDA · 2 min

FDA Grants Early Access to Promising Drug for Pancreatic Cancer

FDA · oncology · 4 min

FDA's New Form 483 Response Guidance: Implications for Pharma

FDA · 3 min

Kyle Diamantas: Rising to Lead the FDA Against All Odds

FDA · 2 min

FDA Approves Expanded Access for Daraxonrasib in Pancreatic Cancer

FDA · oncology · 4 min

FDA Drug Approval Decisions Expected in May 2026: What to Anticipate

FDA · 3 min

AstraZeneca and Daiichi Secure FDA Approval for Datroway in TNBC

FDA · TNBC · 3 min