FDA publishes digital health guidances relating to low-risk general wellness products and clinical decision support software.
Alumis says envudeucitinib delivered high levels of skin clearance in two pivotal Phase 3 trials in moderate-to-severe plaque psoriasis.
FDA says a recent Dexcom 9/18/2025 software correction for its Dexcom G6 and G6 Pro continuous glucose monitoring software is Class 1.
FDA announces a 1/14 town hall to discuss its Quality Management System Regulation (QMSR) and its effective date of 2/2/2026.
FDA releases a list of 13 potential safety signals identified in drugs between 7/2025 and 9/2025.
In a PDUFA 8 reauthorization subgroup discussion, FDA and industry representatives trade data and evaluations of first-cycle reviews and debate whethe...
FDA posts a guidance on Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, D...
FDA releases substantive Warning Letters in the last two weeks of December 2025.
