Regulatory Updates
🇺🇸 FDA Page 4FDA 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 37–48 of 382 articles
FDA approves Merck’s Keytruda for adjuvant NSCLC treatment
FDA · lung cancer · 8 min
Dr. Sarah MitchellEli Lilly's donanemab wins FDA approval for early Alzheimer's disease
FDA · Alzheimer's disease · 6 min
Dr. Sarah MitchellFDA approves Keytruda for adjuvant NSCLC, a Merck catalyst
FDA · lung cancer · 7 min
Dr. Sarah MitchellLenacapavir PrEP shows high HIV-prevention efficacy in Gilead’s Phase 3 trials
oncology · 7 min
Dr. Sarah MitchellVertex launches Journavx after FDA approval for acute pain
FDA · oncology · 9 min
Dr. Sarah MitchellAstraZeneca and Daiichi Sankyo datopotamab deruxtecan hits lung cancer endpoint
oncology · 8 min
Dr. Sarah MitchellFDA approves Keytruda adjuvant NSCLC use in early-stage lung cancer
FDA · oncology · 7 min
Dr. Sarah MitchellFDA approves Keytruda adjuvant NSCLC use: what Merck investors should watch
FDA · oncology · 7 min
Dr. Sarah MitchellNovo Nordisk CagriSema Phase 3 Obesity Results Signal Key Catalyst
EMA · oncology · 5 min
Dr. Sarah MitchellGene Therapy FDA Approval for Rare Disease: Updated List and Analysis
FDA · rare disease · 5 min
Dr. Sarah MitchellFacet Life Sciences Appoints Frank Closurdo as VP, Commercial Services
5 min
Dr. Sarah MitchellAmneal Romidepsin FDA Approval: B2B Analysis for BD Teams and Investors
FDA · 6 min
Dr. Sarah MitchellExplore intelligence