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FDA news and analysis for pharmaceutical BD, investment, and market access · 12 articles on this page

Track critical FDA approvals, regulatory updates, and policy shifts impacting drug development and market access in the US. Stay ahead of compliance.

Showing 217–228 of 391 articles

Medium impact AnalysisMay 31, 2026

BioNTech and Pfizer's Bispecifics Data: Insights and Implications

FDA · 3 min

Dr. Sarah Mitchell
Medium impact NewsMay 31, 2026

FDA's New Guidance on AI: Regulatory Restraint Explained

FDA · 2 min

Dr. Sarah Mitchell
Medium impact AnalysisMay 30, 2026

Can a Chaotic FDA Still Deliver on Faster Drug Development?

FDA · 2 min

Dr. Sarah Mitchell
Medium impact AnalysisMay 30, 2026

Replimune's Third Attempt at Cancer Drug Approval: Insights from FDA Talks

FDA · cancer · 3 min

Dr. Sarah Mitchell
Medium impact NewsMay 30, 2026

Bizengri Receives FDA National Priority Nod for Rare Bile Duct Cancer

FDA · rare bile duct cancer · 2 min

Dr. Sarah Mitchell
Medium impact NewsMay 30, 2026

AI Breast Cancer Risk Prediction Tool Gains FDA Approval

FDA · oncology · 3 min

Dr. Sarah Mitchell
Medium impact NewsMay 30, 2026

States Confront Medical Chatbots Oversight Amid FDA Inaction

FDA · 3 min

Dr. Sarah Mitchell
Medium impact AnalysisMay 30, 2026

Zydus Therapeutics' Saroglitazar Receives FDA Priority Review

FDA · 3 min

Dr. Sarah Mitchell
Medium impact NewsMay 30, 2026

FDA Commissioner Resignation and Its Impact on Drug Approvals

FDA · 3 min

Dr. Sarah Mitchell
Medium impact AnalysisMay 29, 2026

Blood Pressure Tech Market Surge Post-FDA Oversight Changes

FDA · 3 min

Dr. Sarah Mitchell
Medium impact NewsMay 29, 2026

FDA Approves Durvalumab and BCG for High-Risk NMIBC

FDA · oncology · 3 min

Dr. Sarah Mitchell
Medium impact AnalysisMay 29, 2026

FDA Alert: Infectious Diseases Drug News Roundup 2026

FDA · 3 min

Dr. Sarah Mitchell