Drug Approvals
🇺🇸 FDAFDA news and analysis for pharmaceutical BD, investment, and market access
Track global drug approvals & regulatory decisions. Gain critical intelligence on new therapies, market access, and competitive landscapes for pharma BD.
Showing 1–12 of 739 articles
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NovaPharmaNews Drug Approvals hub for FDA covers 739 published articles — news and analysis for pharma BD, investors, and market access teams. Browse related topics below or explore companies, pipeline, and events linked from each story.
FDA MRD guidance in multiple myeloma: what BD teams should track
FDA · multiple myeloma · 6 min
Dr. Sarah MitchellAlembic Wins Tentative FDA Nod for First Generic Larotrectinib Capsules
FDA · NTRK fusion–positive solid tumors · 7 min
Dr. Sarah MitchellFDA priority review advances belzutifan plus pembrolizumab in adjuvant RCC
FDA · adjuvant renal cell carcinoma · 6 min
Dr. Sarah MitchellFDA adds bemotrizinol to sunscreen rules, expanding U.S. UV filter options
FDA · sunburn · 5 min
Dr. Sarah MitchellBiotech coming of age: market analysis of a sector in transition
4 min
Dr. Sarah MitchellFDA approves Vepdegestrant (Veppanu) for ESR1-mutated breast cancer
FDA · estrogen receptor-positive, HER2-negative breast cancer · 6 min
Dr. Sarah MitchellSensorion pivots to SENS-601 after Regeneron’s OTOF hearing loss advance
FDA · hearing loss · 4 min
Dr. Sarah MitchellSLS Stock Jumps on Biotech Momentum as SELLAS Gains 25.10%
4 min
Dr. Sarah MitchellMedicare GLP-1 coverage 2026: Bridge program starts July 1
GLP-1 · 7 min
Dr. Sarah MitchellFDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria
FDA · rheumatoid arthritis · 6 min
Dr. Sarah MitchellFDA Drug Approval: What Approval Means for Pharma Marketing and BD
FDA · 5 min
Dr. Sarah MitchellVanda tradipitant update: FDA re-review extends to Dec. 5, 2025
FDA · 6 min
Dr. Sarah MitchellFrequently asked questions
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New articles are published continuously as regulatory, clinical, and commercial signals break. Use the content-type filters for latest news vs in-depth analysis.
Where does this coverage come from?
Editorial intelligence combines FDA openFDA, ClinicalTrials.gov, SEC EDGAR, congress calendars, and analyst reporting. See our data sources policy for attribution.
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