Regulatory Updates
🇺🇸 FDA Page 12FDA news and analysis for pharmaceutical BD, investment, and market access · 12 articles on this page
Track global pharma regulatory policy changes, FDA, EMA, and other agency guidelines impacting drug development and market access. Stay ahead.
Showing 133–144 of 382 articles
Tissue TMB Superior to Blood TMB in Predicting Immunotherapy Response, Cleveland Clinic Study Finds
Celcuity's Gedatolisib: Navigating the Path to Broad FDA Approval in Breast Cancer
FDA Delays Decision on AstraZeneca's Camizestrant Following Negative Adcomm Vote
FDA Declines Cingulate's ADHD Drug CTx-1301 Over Manufacturing Concerns
ASCO 2026 Preview: Key Data and Trends in Cancer Research
Experimental pancreatic cancer drug offers new hope in major trial
This Week in Breast Cancer: Camizestrant Delay, Bria-IMT Data, Recurrence Test
Organon (OGN) to be Acquired by Sun Pharma for $14.00 Cash per Share
FDA Clears Iovance IL-12 TIL Trial, Signaling New Frontier in Solid Tumor Therapy
FDA Approves Ensitrelvir for Post-Exposure Prophylaxis of COVID-19
How one state’s medical meal program lowered health care costs
FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients