The U.S. Food and Drug Administration (FDA) granted accelerated approval for Trodelvy, a drug therapy for patients with locally advanced or metastatic urothelial cancer (mUC), an aggressive disease with a survival rate of 5.5%. Previously, Trodelvy was granted...
The U.S. Food and Drug Administration (FDA) announced de novo clearance of GI Genius™, a revolutionary AI device for colonoscopy. The device is the first of its kind, and was developed by Cosmo Pharmaceuticals, with exclusive distribution rights to Medtronic....
The U.S. Food and Drug Administration (FDA) announced today an actionable plan, called Closer to Zero, to reduce the exposure of toxic elements in foods commonly consumed by babies and young children. While FDA’s testing results have shown that there is no...
The U.S. Food and Drug Administration (FDA) has granted Donisi De Novo clearance for its contact-free multiparameter measurement system. The innovative system is backed by 26 patents and consists of a combination of artificial intelligence (AI), algorithms, and...
Eli Lilly and Incyte’s atopic dermatitis drug received extended supplemental New Drug Application (NDA) review by the U.S. Food and Drug Administration (FDA) for baricitinib, a drug therapy intended for patients with moderate-to-severe conditions. The extension...
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