FDA Grants Second Approval for Gilead’s Trodelvy
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...
FDA Approves of Revolutionary AI Device for Colonoscopy
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....
FDA Announces Closer to Zero Plan to Reduce Toxic Elements from Baby Food
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 immediate...
Donisi De Novo Granted FDA Clearance for Contact-Free Multiparameter Measurement System
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 Receives Extended Supplemental NDA Review
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 came...
FDA Grants 510(k) Clearance for Respinova’s Pulsehaler
The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Respinova to market their device that clears secretions for patients with respiratory issues by facilitating the opening of airways. The device, called Pulsehaler, is the first to use patented...