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Sunday, June 14, 2026

Regulatory Updates

🇺🇸 FDA Page 3

FDA 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

Critical impact AnalysisJun 7, 2026

Novartis remibrutinib wins Phase 3 in chronic spontaneous urticaria

chronic spontaneous urticaria · 8 min

Dr. Sarah Mitchell
Critical impact AnalysisJun 7, 2026

EMA backs datopotamab deruxtecan for advanced lung cancer

EMA · lung cancer · 10 min

Dr. Sarah Mitchell
High impact NewsJun 7, 2026

FDA approves Vyloy for HER2-negative gastric and GEJ cancer

FDA · HER2-negative gastric cancer · 5 min

Dr. Sarah Mitchell
High impact AnalysisJun 7, 2026

AbbVie closes $8.7B Cerevel deal as neuroscience pipeline expands

U.S. Federal Trade Commission · immunology · 5 min

Dr. Sarah Mitchell
Critical impact AnalysisJun 7, 2026

Lenacapavir posts 100% HIV prevention in PURPOSE 1

FDA · HIV · 8 min

Dr. Sarah Mitchell
High impact NewsJun 7, 2026

J&J reports positive Phase 3 Tremfya data in ulcerative colitis

CHMP · ulcerative colitis · 7 min

Dr. Sarah Mitchell
High impact NewsJun 7, 2026

FDA approves Dupixent for COPD with eosinophilic phenotype

FDA · chronic obstructive pulmonary disease · 6 min

Dr. Sarah Mitchell
High impact NewsJun 7, 2026

GSK Blenrep wins FDA approval in relapsed multiple myeloma

FDA · blood cancer · 6 min

Dr. Sarah Mitchell
Critical impact NewsJun 7, 2026

Moderna's mRNA-1083 Phase 3 shows stronger flu and COVID immune responses

FDA · COVID-19 · 7 min

Dr. Sarah Mitchell
Critical impact AnalysisJun 7, 2026

FDA Approves Vertex’s First-in-Class Non-Opioid Pain Drug Journavx

FDA · moderate-to-severe acute pain · 8 min

Dr. Sarah Mitchell
Critical impact NewsJun 7, 2026

FDA approves Keytruda for adjuvant NSCLC treatment, expanding Merck’s lung cancer label

FDA · lung cancer · 6 min

Dr. Sarah Mitchell
Critical impact AnalysisJun 7, 2026

Novo Nordisk CagriSema Phase 3 Results: Obesity Catalyst Update

EMA · obesity · 7 min

Dr. Sarah Mitchell