FDA accepts for review a Biohaven Pharmaceutical Holding supplemental NDA for Nurtec ODT (rimegepant) for preventing migraines.
FDA places a clinical hold on a Voyager Therapeutics planned clinical trial for VY-HTT01 for treating Huntingtons disease.
Researchers say FDA could ensure better evidence in medical device de novo clearances by requiring that devices meet prespecified effectiveness endpoi...
FDA clears an ImmersiveTouch 510(k) for its ImmersiveView Surgical Plan digital surgery platform.
Hogan Lovells attorneys say that new FDA and CMS drug importation provisions are unlikely to lead to any increase in drugs imported from Canada or low...
The NIH puts a safety hold on the Abbott ACTIV-3 trial of a Covid-19 antibody therapy.
FDA releases its latest batch of Warning Letters that include Haloderm and Oneness Labs.
FDA grants miR Scientific a Breakthrough Device Designation for its miR Sentinel PCC4 Assay for prostate cancer analysis.