The following products no longer have a REMS requirement: Abecma; Breyanzi; Carvykti; Kymriah; Tecartus; and Yescarta. The Food and Drug Administration (FDA) has removed the Risk Evaluation and ...

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 ...

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 ...

In the U.S., schizophrenia remains one of the most severe and debilitating mental health conditions, with effective treatment often out of reach for those who need them most. Clozapine, a medication ...

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 ...

The U.S. Food and Drug Administration removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa (vandetanib), a thyroid cancer medication manufactured by Sanofi SA’s (NASDAQ: ...