FDA Approves Targeted Treatment for Rare DMD Mutation

The Food and Drug Administration (FDA) has granted approval for Amondys 45 (casimersen; Sarepta Therapeutics Inc.) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45...

FDA Safety Alert: Medtronic Valiant Navion

The Food and Drug Administration (FDA) has announced a voluntary recall of unused Medtronic Valiant Navion thoracic stent graft systems. The Valiant Navion thoracic stent graft system is indicated for the endovascular repair of all lesions of the descending thoracic...

FDA Safety Alert: EMBLEM S-ICD

The Food and Drug Administration (FDA) has announced a recall of specific lots of the Boston Scientific EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) due to a manufacturing error. The EMBLEM S-ICD is part of the Boston Scientific S-ICD System. The...