Federal Register notice: FDA releases a draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labelin...
FDA assigns a PDUFA action date of 11/13 for a PharmaEssentia BLA for ropeginterferon alfa-2b-njft to treat polycythemia vera, a rare blood cancer.
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 ...