Olympus recalls (Class 1) its ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured before 5/12 after receiving reports of device components detaching ...
FDA issues an early alert after becoming aware that Abiomed had issued a letter to affected customers recommending certain Automated Impella Controlle...
FDA issues Biogen a complete response letter on a supplemental NDA for a high-dose regimen of Spinraza (nusinersen) for treating spinal muscular atrop...
FDA posts a final guidance outlining how the agency will decide when to temporarily allow use of unapproved diagnostic tests during a declared public ...
FDA grants accelerated approval to a Stealth Biotherapeutics NDA for Forzinity (elamipretide) injection for treating Barth syndrome.
FDA rejects Otsuka Pharmaceutical and H. Lundbecks sNDA to expand the use of Rexulti (brexpiprazole) for treating post-traumatic stress disorder in ad...
FDA takes two actions against autism by ordering a label change against acetaminophen (Tylenol) use in pregnancy approving leucovorin calcium tablets ...
FDA extends by three months its review of Sanofis multiple sclerosis drug tolebrutinib to evaluate additional analyses submitted recently.
