FDA recommends that uniQure conduct a randomized, double-blind, sham surgery-controlled trial before seeking BLA approval for its Huntingtons disease ...
FDA approves a Synergy Spine Solutions PMA for its Synergy Disc, a motion-preserving artificial cervical disc.
A leading myeloma researcher says FDAs draft guidance endorsing minimal residual disease as a potential basis for accelerated drug approvals in multip...
Drug user fee negotiators confront lingering divisions over FDAs America First proposals and the structure of hiring commitments, according to just-po...
The U.S. Department of Justice (DoJ) says a Federal Circuit ruling on so-called generic drug skinny labels threatens to undermine the Hatch-Waxman fra...
Rare disease drug developers and patient advocates are applauding a series of new guidance documents from FDA that bring long-awaited clarity to regul...
The U.S. Senate Special Committee on Aging raises concerns about FDAs handling of foreign drug manufacturing violations and how those decisions could ...
FDA accepts for priority review an Ionis Pharmaceuticals supplemental NDA for olezarsen for treating severe hypertriglyceridemia.
