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.
FDA denies a Fresenius petition asking it not to approve a Keryx sNDA for Auryxia.
FDA commissioner Scott Gottlieb describes steps the agency is taking to facilitate approval of shared system REMS in an effort to prevent innovators f...