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FDA issues Scholar Rock a complete response letter for its BLA seeking approval of apitegromab, indicated for treating spinal musc...[ Price : $8.95]
FDA publishes a guidance with recommendations for computer software assurance in computers and automated data processing systems i...[ Price : $8.95]
FDA releases the form FDA-483 with two observations from an inspection at the Genzyme Ireland drug manufacturing facility in Water...[ Price : $8.95]
FDA releases the form FDA-483 with six observations from an inspection at the Cohance Lifesciences drug manufacturing facility in ...[ Price : $8.95]
Sens. Rick Scott and Kirsten Gillibrand ask FDA commissioner Martin Makary to answer 11 questions about the agencys oversight of o...[ Price : $8.95]
Olympus recalls (Class 1) its ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured before 5/12 after receiving reports of device c...[ Price : $8.95]
FDA issues an early alert after becoming aware that Abiomed had issued a letter to affected customers recommending certain Automat...[ Price : $8.95]
FDA issues Biogen a complete response letter on a supplemental NDA for a high-dose regimen of Spinraza (nusinersen) for treating s...