Karyopharm Therapeutics says it will submit an NDA in the second half of this year for selinexor for multiple myeloma after reporting positive top-lin...
FDA clears a Conavi Medical 510(k) for its Novasight Hybrid System, which allows simultaneous imaging of coronary arteries with both intravascular ult...
FDA approves a Novartis NDA for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of certain patients with me...
FDA warns Fusion IV Pharmaceuticals about multiple violations in its production of compounded drugs as an outsourcing facility.
Attorneys appearing on a Washington Legal Foundation webinar discuss two Justice Department memos that bear on False Claims Act cases.
FDA releases its latest batch of Warning Letters that includes one medical product maker Fusion IV Pharmaceuticals.
FDA clears a Med-El USA 510(k) for its next generation non-surgical bone conduction hearing technology called AdHear.
PhRMA and AstraZeneca give FDA five points to clarify in an addendum to a draft International Conference on Harmonization guidance on clinical trial s...