FDA approves a Medtronic PMA of its new Avalus pericardial aortic surgical valve for treating aortic valve disease.
Federal Register notice: FDA announces the fee rates and payment procedures for fiscal year 2018 generic new animal drug user fees.
Federal Register notice: FDA announces the fiscal year 2018 rates for the establishment and re-inspection fees related to entities that compound human...
FDA and TG Therapeutics reach an agreement on a special protocol assessment on the design of two Phase 3 clinical trials for TG-1101 (ublituximab), a ...
A National Bureau of Economic Research working paper says more study into how much generic drug prices have increased over time is warranted.
FDA accepts for priority review an AstraZeneca NDA for acalabrutinib, a highly-selective Bruton tyrosine kinase inhibitor for treating patients with r...
FDA approves Pharmacyclics Imbruvica for a new indication to treat chronic graft versus host disease after failure of one or more treatments.
Attorney Suzan Onel says FDA has an ambitious series of steps it plans to take through the first quarter of 2018 as part of its new digital innovation...