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