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

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 landscape is evolving daily. As always, readers are advised to consult original sources and official health guidance for more details. Sources: Key information has been drawn from Reuters, AP News, FDA/CDC releases, and expert commentary to ensure accuracy and timeliness reuters.com reuters.com reuters.com thewellnews.com reuters.com
25 August 2025
Miracle Drugs, Mega Mergers & Outbreak Alerts – Biotech & Health News Roundup (Aug 15–16, 2025)

Miracle Drugs, Mega Mergers & Outbreak Alerts – Biotech & Health News Roundup (Aug 15–16, 2025)

Wegovy (semaglutide) received FDA accelerated approval to treat metabolic dysfunction-associated steatohepatitis (MASH), becoming the first GLP-1 therapy cleared for MASH in a patient population estimated at about 5% of U.S. adults, based on part 1 of an ongoing trial showing liver health improvement. Tonix Pharmaceuticals’ Tonmya, or TNX-102 SL, was approved August 15 for fibromyalgia, the first new fibromyalgia therapy in 15 years, with two Phase 3 trials showing significantly reduced daily pain versus placebo at 14 weeks and a potential peak U.S. sales of about $800 million. Pfizer’s inclacumab, a P-selectin inhibitor acquired via the 2022 $5.4 billion Global
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