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.
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...
