FDA issues Scholar Rock a complete response letter for its BLA seeking approval of apitegromab, indicated for treating spinal muscular atrophy.
FDA publishes a guidance with recommendations for computer software assurance in computers and automated data processing systems in medical device pro...
FDA releases the form FDA-483 with two observations from an inspection at the Genzyme Ireland drug manufacturing facility in Waterford, Ireland.
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...
