FDA issues a warning to patients and consumers about regenerative medicine therapies.
FDA clears a Medtronic 510(k) for patient-specific UNiD Rods for use with its CD Horizon, Solera, Voyager and Infinity OCT spinal systems.
FDA grants priority review for an Amryt NDA for oleogel-S10 to treat epidermolysis bullosa.
Dermavant Sciences submits an NDA for tapinarof for treating mild, moderate and severe plaque psoriasis in adult patients.
An 11th Circuit Appeals Court panel upholds a Florida district court decision in favor of FDA in a suit against US Stem Cell Clinic.
FDA says healthcare providers should no longer implant the Medtronic Heartware Ventricular Assist Device system that the company is no longer selling ...
FDA posts a draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations.
FDA accepts for review a Liquidia NDA resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension.