Regulatory Updates
🇺🇸 FDA Page 3FDA 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 25–36 of 382 articles
Novartis remibrutinib wins Phase 3 in chronic spontaneous urticaria
chronic spontaneous urticaria · 8 min
Dr. Sarah MitchellEMA backs datopotamab deruxtecan for advanced lung cancer
EMA · lung cancer · 10 min
Dr. Sarah MitchellFDA approves Vyloy for HER2-negative gastric and GEJ cancer
FDA · HER2-negative gastric cancer · 5 min
Dr. Sarah MitchellAbbVie closes $8.7B Cerevel deal as neuroscience pipeline expands
U.S. Federal Trade Commission · immunology · 5 min
Dr. Sarah MitchellLenacapavir posts 100% HIV prevention in PURPOSE 1
FDA · HIV · 8 min
Dr. Sarah MitchellJ&J reports positive Phase 3 Tremfya data in ulcerative colitis
CHMP · ulcerative colitis · 7 min
Dr. Sarah MitchellFDA approves Dupixent for COPD with eosinophilic phenotype
FDA · chronic obstructive pulmonary disease · 6 min
Dr. Sarah MitchellGSK Blenrep wins FDA approval in relapsed multiple myeloma
FDA · blood cancer · 6 min
Dr. Sarah MitchellModerna's mRNA-1083 Phase 3 shows stronger flu and COVID immune responses
FDA · COVID-19 · 7 min
Dr. Sarah MitchellFDA Approves Vertex’s First-in-Class Non-Opioid Pain Drug Journavx
FDA · moderate-to-severe acute pain · 8 min
Dr. Sarah MitchellFDA approves Keytruda for adjuvant NSCLC treatment, expanding Merck’s lung cancer label
FDA · lung cancer · 6 min
Dr. Sarah MitchellNovo Nordisk CagriSema Phase 3 Results: Obesity Catalyst Update
EMA · obesity · 7 min
Dr. Sarah MitchellExplore intelligence