FDA releases the form FDA-483 with six observations from an inspection at the Cohance Lifesciences drug manufacturing facility in Secunderabad, India.
Sens. Rick Scott and Kirsten Gillibrand ask FDA commissioner Martin Makary to answer 11 questions about the agencys oversight of overseas generic drug...
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...
