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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...[ Price : $8.95]
FDA extends by three months its review of Sanofis multiple sclerosis drug tolebrutinib to evaluate additional analyses submitted r...[ Price : $8.95]
Roche reports positive Phase 3 data with its investigational breast cancer drug giredestrant.[ Price : $8.95]
FDA posts a draft guidance entitled Malaria: Developing Drugs for Treatment that outlines key considerations for companies develop...