FDA Cmte. Likes Vytorin Safety In SHARP, But Worries About Dose Escalation
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FDA Cmte. To Weigh Breadth Of Vytorin/Zetia CV Risk Reduction Claim In Renally Impaired Patients
The Endocrinologic and Metabolic Drugs Advisory Committee will vote Nov. 2 on whether a new claim for reducing the risk of major cardiovascular events based upon the SHARP study should apply to both the pre-dialysis and dialysis populations.
SEARCH Ends Badly For Simvastatin 80 Mg; FDA Restricts Use To Existing Patients
New clinical trial data and adverse event reports show high-dose simvastatin-containing products have a greater risk for muscle toxicity than other statins, the agency concludes.
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.