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FDA approves a Foldax IDE to begin a clinical study of its Tria biopolymer mitral surgical heart valve.[ Price : $8.95]
FDA grants Gannex a fast track designation for its non-alcoholic steatohepatitis (NASH) drug candidate ASC42, which the company de...[ Price : $8.95]
FDA approves a shorter two-hour infusion time for Genentechs Ocrevus (ocrelizumab) dosed twice-yearly for those living with relap...[ Price : $8.95]
A just-filed citizen petition requests that FDA not treat daily-wear uniform scrubs as medical devices.[ Price : $8.95]
FDA discusses the agencys surrogate endpoint (SE) table that was mandated by the 21st Century Cures Act of 2016.[ Price : $8.95]
Federal Register notice. FDA makes available three device-specific final guidance documents for the Safety and Performance Based P...[ Price : $8.95]
FDA approves Revivicors intentional genomic alteration in GalSafe pigs for use as food and human therapeutics.[ Price : $8.95]
Federal Register notice: FDA corrects an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Indu...