Regulatory Updates

Summit Pipeline Approvals and Competitive Outlook: 2023-2024 Update

6 min

Listeria Outbreaks 2026: FDA and CDC Soft Cheese Recall Analysis for Pharma

FDA · oncology · 6 min

5 Notable Oncology FDA Approvals Granted in May: A B2B Analysis

FDA · oncology · 6 min

Weekly Buzz: PHG, KMDA Win FDA Nod; FULC Halts Pociredir; RMD Closes Noctrix Deal; NVS Paces In IgAN

FDA · IgAN · 6 min

The FDA Amendments Act And Drug Safety: Twenty Years Later

FDA · 5 min

FDA Issues June 2026 Guidance: Gene Therapy, Payor Comms, and CMC Flexibilities

FDA · 4 min

Friday Five: ASCO Takeaways, ADA Focus, China Deals & More – Clinical Trials

4 min

May 2026 FDA Oncology Actions: 8 Approvals Reshape the Landscape

FDA · oncology · 5 min

FDA clears U.S. trial of MAIA lung cancer drug for third-line patients

FDA · lung cancer · 6 min

Pharma bets on PD-1/VEGF bispecifics: Is lung cancer the wrong target?

FDA · non-small cell lung cancer · 5 min

Abivax colitis drug hits goal, but cancer cases rattle investors

colitis · 5 min

Supreme Court sides with generic drug maker in icosapent ethyl patent case

U.S. Supreme Court · severe hypertriglyceridemia · 6 min