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,…
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Breakthroughs in Biotech & Pharma Big Deals & Industry Moves Regulatory & Health Policy Updates Public Health Developments Noteworthy Medical Research Healthcare Technology & Innovation Sources: Original news reports, press releases and scientific publications from Aug 14–15, 2025 fda.gov fiercebiotech.com fiercepharma.com paho.org fiercebiotech.com, as cited above. Each development is attributed to reputable sources including FDA…
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Breakthroughs in Biotech & Pharma Big Deals & Industry Moves Regulatory & Health Policy Updates Public Health Developments Noteworthy Medical Research Healthcare Technology & Innovation Sources: Official press releases, government health agency updates, and reputable media coverage were used in this report (including Reuters, Fierce Biotech/Pharma, Bloomberg, FDA/CDC/DSHS releases, and peer-reviewed journals). All source links…
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Researchers in China unveiled a hydrogel-based “smart” wound dressing that speeds diabetic ulcer healing, with a single application achieving about 90% wound closure in 12 days by delivering microRNA-loaded vesicles that suppress the vessel-growth inhibitor TSP-1. A Swedish study published August 8 identified 87 DNA methylation sites in blood from 752 newly diagnosed diabetics followed…
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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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Scientific Breakthroughs & Discoveries (Aug 7–8, 2025) Regulatory Updates (FDA and Other Agencies) Mergers, Acquisitions & Financial News Public Health & Policy Updates Sources: The information above is sourced from recent press releases, regulatory announcements, and news reports between Aug 7–8, 2025, including Scripps Research eurekalert.org eurekalert.org, EurekAlert! eurekalert.org, Boston Globe kffhealthnews.org bostonglobe.com, UC Davis Health…
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On July 2, 2025, the FDA granted accelerated approval to linvoseltamab (Lynozyfic), a BCMA-targeting bispecific antibody, for adults with heavily pretreated relapsed/refractory multiple myeloma, after trials showed a 70% response rate. Also on July 2, 2025, the FDA approved sunvozertinib (Zegfrovy) as the first targeted oral therapy for advanced NSCLC with EGFR exon 20 insertion…
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3I/ATLAS, an interstellar comet, was detected on July 1, 2025, possibly 10 km across, and is the third known interstellar visitor after ʻOumuamua (2017) and Borisov (2019). <li NASA’s Parker Solar Probe captured the closest-ever images of the Sun’s corona and solar wind from 3.8 million miles away during a December 24, 2024 flyby. <li…
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Pfizer Inc., in collaboration with BioNTech, co-developed the first FDA-approved mRNA COVID-19 vaccine, Comirnaty. Roche Holding AG is the world’s largest biotech company and a leader in oncology treatments (Herceptin) and diagnostics. Moderna, Inc. pioneered mRNA vaccine technology and its COVID-19 vaccine was among the first mRNA medicines approved, while expanding mRNA therapeutics for cancer…
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