[ Price : $8.95]
FDA publishes digital health guidances relating to low-risk general wellness products and clinical decision support software.[ Price : $8.95]
FDA posts a guidance on Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of...[ Price : $8.95]
FDA releases substantive Warning Letters in the last two weeks of December 2025.[ Price : $8.95]
FDA releases the form FDA-483 with three observations from an inspection at the Sun Pharmaceutical Medicare sterile drug manufactu...[ Price : $8.95]
A Hyman, Phelps & McNamara CMC regulatory expert lists the initial industry recommendations for improvements to be negotiated in t...[ Price : $8.95]
FDA accepts for review an Inovio BLA for INO-3107 as a potential treatment for adults with recurrent respiratory papillomatosis.[ Price : $8.95]
Alumis says envudeucitinib delivered high levels of skin clearance in two pivotal Phase 3 trials in moderate-to-severe plaque psor...[ Price : $8.95]
FDA says a recent Dexcom 9/18/2025 software correction for its Dexcom G6 and G6 Pro continuous glucose monitoring software is Clas...