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Tag: FDA

FDA Shockers, Breakthrough Trials & Outbreak Alerts – Biotech & Health News Roundup (Aug 24–25, 2025)

Regulatory Announcements: Approvals & Rejections Clinical Trial Breakthroughs & Research Highlights Industry Deals, Mergers & Investments Public Health Policy & Governance Updates Emerging Diseases & Vaccine News This comprehensive roundup highlights the fast-moving developments in biotech, pharma, and health over the past 48 hours. From life-saving drugs and high-stakes deals to public health challenges, the…
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Breakthrough Trials, FDA Greenlights & Global Health Alerts: Biotech & Health News (Aug 10–11, 2025)

Novartis announced that two Phase III trials, NEPTUNUS-1 and NEPTUNUS-2, met their primary endpoints in Sjögren’s disease, marking the first global Phase III evidence of significant disease activity reduction with ianalumab and its dual B-cell depletion and BAFF signaling blockade. IO Biotech will disclose topline results from its Phase III melanoma trial of Cylembio (IO102-IO103)…
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Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)

Drug Approvals & Regulatory Developments (In Europe, regulators also made news: the EMA’s committee recommended approving darolutamide (Bayer’s Nubeqa) with hormone therapy for metastatic prostate cancer based on positive Phase 3 data onclive.com.) Clinical Trials & Research Breakthroughs Public Health & Policy Industry & Business Updates Sources: Key information and quotes in this report were…
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