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Federal Register notice. FDA makes available a draft guidance for industry on Use of a Drug Master File for Shared System REMS Sub...[ Price : $8.95]
FDA approves Mercks Prevymis (letermovir) once-daily tablets for oral use and injection for intravenous infusion, indicated for pr...[ Price : $8.95]
FDA clears a DT MedTech 510(k) for its Hintermann Series H2 Total Ankle Replacement System.[ Price : $8.95]
CDER issues a MAPP detailing how generic drug ANDAs, amendments, and supplements will be prioritized for review.[ Price : $8.95]
Bloomberg News says former Lilly executive Alex Azar is likely to be named HHS secretary.[ Price : $8.95]
FDA approves a Seattle Genetics supplemental BLA for Adcetris (brentuximab vedotin) for treating adult patients with primary cutan...[ Price : $8.95]
FDA accepts an Otsuka Pharmaceutical Co. NDA resubmission for tolvaptan and its expanded use in treating adults with Autosomal Dom...[ Price : $8.95]
FDA awards Advanced Clinical Trials for Children and Duke University each $1 million to help advance pediatric clinical trials.