FDA publishes digital health guidances relating to low-risk general wellness products and clinical decision support software.
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.
FDA releases the form FDA-483 with three observations from an inspection at the Sun Pharmaceutical Medicare sterile drug manufacturing facility in Hal...
A Hyman, Phelps & McNamara CMC regulatory expert lists the initial industry recommendations for improvements to be negotiated in the BsUFA reauthoriza...
FDA accepts for review an Inovio BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis.
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.
