A joint FDA advisory committee on Tuesday overwhelming voted to eliminate the risk evaluation and mitigation strategy (REMS) program designed around the risk for severe neutropenia associated with ...
Agios Pharmaceuticals AGIO announced that the FDA has approved Aqvesme (mitapivat) for the treatment of adult patients with alpha- or beta-thalassemia. With this approval, Aqvesme becomes the only FDA ...
The FDA still recommends prescribers monitor patients’ ANC levels according to the prescribing information. The Food and Drug Administration (FDA) has removed the risk evaluation and mitigation ...
US regulators removed a special safety program intended to monitor for certain heart risks with vandetanib (Caprelsa), a drug first approved in 2011 to treat medullary thyroid cancer in patients whose ...
Health care providers will no longer need to do extra monitoring beyond what is expected with standard clinical care. The Food and Drug Administration (FDA) has deemed the Risk Evaluation and ...
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