FDA approves a SpringWorks Therapeutics NDA for Gomekli (mirdametinib) for treating certain patients with neurofibromatosis Type 1.
FDA accepts for review a Regeneron Pharmaceuticals BLA resubmission for linvoseltamab for treating adult patients with relapsed/refractory multiple my...
Former FDA commissioner Scott Gottlieb says the agency should revert to clinical decision support system regulatory policies approved during his tenur...
FDA says Jeremy Brown of Simi Valley, CA has been sentenced for introducing unapproved drugs into interstate commerce.
Sentec/Percussionaire recalls its Phasitron breathing circuit kits after receiving a complaint that the venturi component of the kit stopped oscillati...
Pliant Therapeutics pauses enrollment and dosing due to an undisclosed safety concern in its ongoing BEACON-IPF Phase 2b trial of bexotegrast in patie...
FDA posts a final guidance entitled Institutional Review Board (IRB) Written Procedures that is intended to harmonize FDA and HHS Office for Human Res...
Boehringer Ingelheim plans to submit an NDA for nerandomilast for treating progressive pulmonary fibrosis following its release of positive data from ...
