Sunovion Pharmaceuticals files a supplemental NDA to expand the indication for its antiepileptic drug Aptiom (eslicarbazepine acetate) to include use ...
Researchers from a number of institutions, led by former FDA principal deputy commissioner Josh Sharfstein, develop a new Blueprint for Transparency a...
FDA approves Novartiss Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women wit...
FDA clears a Medtronic 510(k) for its Reveal LINQ Insertable Cardiac Monitor with TruRhythm Detection, an advanced cardiac monitor offering designed t...
For the first time in our 35-year history of FDA news coverage, we endorse a candidate for FDA commissioner: Trumps choice of former deputy commission...
FDA seeks comments on its ongoing efforts to enhance mechanisms for patient engagement at the agency, including establishing a new Office of Patient A...
Former FDA commissioner Andrew von Eschenbach co-authors an opinion piece on increased resources needed to advance activities such as the Critical Pat...
FDA posts a guidance on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims that is intended to help applicants in developing lab...