When added to corticosteroids, treatment with the investigational agent givinostat led to statistically and clinical meaningful benefits in ambulatory children with Duchenne muscular dystrophy (DMD) compared […]
Share on PinterestMeasles outbreaks have been reported in multiple states this year in the U.S. and cases are rising globally. jure/Getty Images The CDC issued a […]
Share on PinterestAdults who were exposed to tobacco at an early age may have an increased risk for type 2 diabetes. Jeffrey Glas/Getty Images A study […]
Date Issued Type Title Statements 3/19/2024 Proposed Rule Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B […]
By: Cassandra L. Taylor, public health advisor, Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Schuyler Pruyn, project manager, Office of […]
The US Food and Drug Administration (FDA) has approved aprocitentan (Tryvio) to lower blood pressure, in combination with other antihypertensive agents, in adults with treatment-resistant hypertension. […]
TOPLINE: Despite the risk of worsening acne with progestin-only long-acting reversible contraception (LARC) in a study of adolescents and young adults, acne alone was not a […]
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only […]
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