Regulatory Updates

FDA Approves Generic Eribulin Mesylate for Metastatic Breast Cancer

FDA · breast cancer · 5 min

Impact of CDER Leadership Changes on Pharma Strategy

FDA · 5 min

FDA Declines Guidance on Foreign Drug Imports: Impact on Pharma BD and Investors

FDA · 6 min

New Hormone Regimen Shows Promise for Prostate Cancer Surgery Patients: Study Insights

FDA · prostate cancer · 6 min

The Hidden History of BPC-157: Unlocking Pharma Opportunities

FDA · regenerative medicine · 6 min

Eisai's Leqembi Sales Forecast: A Turning Point?

FDA · Alzheimer's · 7 min

FDA seeks to cut repeat work for gene therapy developers

FDA · gene therapy · 6 min

Ophthalmology Pipeline Milestones for Q2 2026: Key Catalysts and Investor Insights

FDA · ophthalmology · 6 min

FDA Hold Puts Aardvark Prader-Willi Drug in Limbo: Implications for Pharma BD

FDA · Prader-Willi syndrome · 8 min

Friedreich's Ataxia and Obesity Treatment Updates: Design Therapeutics and Vincentage Insights

FDA · obesity · 7 min

Ebola Response Shift: Trump Administration's New Playbook and Pharma Implications

FDA · Ebola · 7 min

Real-World Data from EHRs and Claims: Strengths, Limitations, and Regulatory Impact

FDA · 7 min