Risk evaluation and mitigation strategy (REMS) programs help ensure that the benefits of certain high-risk medications outweigh their risks. With the routine use of REMS programs, however, concerns ...

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 FDA has officially eliminated clozapine's risk evaluation and mitigation strategy (REMS) program, with all REMS operations stopped as of June 13. The announcement comes several months after a ...

The US Food and Drug Administration will no longer require aprocitentan (Tryvio), a novel endothelin receptor antagonist, to be part of its drug safety program, according to an announcement from ...

To REMS, or not to REMS. That, apparently, was the question for Cytokinetics, which has seen any potential approval for its experimental heart drug delayed by an extra three months over an unusual ...

Prescribers and pharmacists are no longer expected to comply with the REMS for Tryvio. The Food and Drug Administration (FDA) has removed the risk evaluation and mitigation strategies (REMS) program ...

Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now. The FDA has removed the Risk Evaluation and ...

According to the FDA, the labeling alone should be adequate to communicate the risk of embryofetal toxicity. The Food and Drug Administration (FDA) has removed the Risk Evaluation and Mitigation ...

With clinician approval, reproductive-age patients prescribed isotretinoin-containing drugs for acne may complete required pregnancy testing at home or in other non-medical settings, the FDA announced ...

It was only about a year ago that the biopharma industry hailed a decision by the Supreme Court to preserve access to mifepristone, a drug most commonly known for its paired use with another medicine ...