Federal Register notice. FDA makes available a draft guidance for industry on Use of a Drug Master File for Shared System REMS Submissions.
FDA approves Mercks Prevymis (letermovir) once-daily tablets for oral use and injection for intravenous infusion, indicated for preventing cytomegalov...
FDA clears a DT MedTech 510(k) for its Hintermann Series H2 Total Ankle Replacement System.
CDER issues a MAPP detailing how generic drug ANDAs, amendments, and supplements will be prioritized for review.
Bloomberg News says former Lilly executive Alex Azar is likely to be named HHS secretary.
FDA approves a Seattle Genetics supplemental BLA for Adcetris (brentuximab vedotin) for treating adult patients with primary cutaneous anaplastic larg...
FDA accepts an Otsuka Pharmaceutical Co. NDA resubmission for tolvaptan and its expanded use in treating adults with Autosomal Dominant Polycystic Kid...
FDA awards Advanced Clinical Trials for Children and Duke University each $1 million to help advance pediatric clinical trials.