Deficiencies in interferon-stimulated gene 15 (ISG15), a protein that normally regulates the immune response, causes mild but persistent inflammation. However, its absence also provides an unexpected advantage by increasing resistance to viral infections. Inspired by this condition and using mRNA technology, scientists at Columbia University and the Icahn School of Medicine at Mount Sinai have developed a broad-spectrum antiviral platform.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Alvotech, Advanz, Beone, Bioaegis, Biodlink, Crinetics, Keros, Medicus, Realta, Regeneron, Rhythm, Stealth, Veogen.
The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.
Multiple datasets are due to roll out soon in the Prader-Willi syndrome (PWS) space, where contenders are trying varied mechanisms of action to tackle the rare genetic disorder characterized by insatiable hunger, or hyperphagia. In the mix are Aardvark Therapeutics Inc., Acadia Pharmaceuticals Inc., Rhythm Pharmaceuticals Inc. and Soleno Therapeutics Inc.
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