FDA clears a Neo Medical 510(k) for the use of its Pedicle Screw System in late stage tumor indications in combination with Osartis BonOs Inject cemen...
FDA accepts for priority review a United Therapeutics NDA for Tyvaso DPI (inhaled treprostinil) for treating pulmonary arterial hypertension.
FDA opens a five-year collaboration with ConcertAI to evaluate real-world outcomes and safety in cancer treatments.
Attorney Jeffrey Shapiro says legislation sponsored by Sen. Rand Paul to have CMS take the lead in the regulation of laboratory-developed tests could ...
Federal Register notice: FDA seeks comments on the use of study data exchange standards from stakeholders involved in study conduct, data collection, ...
Federal Register notice: FDA announces that it received a petition requesting exemption from the premarket notification requirements for the generic d...
OGD Office of Research and Standards director Robert Lionberger describes steps FDA has taken to foster the development of complex generic drugs.
FDA says Sanofi did not submit sufficient data to justify approving an Aubagio sNDA for an indication for pediatric patients with relapsing forms of m...