The US Food and Drug Administration (FDA) has been using the Risk Evaluation and Mitigation Strategies (REMS) program as a way to mitigate adverse events stemming from opioid misuse and abuse, but ...
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 US Food and Drug Administration (FDA) announced changes to its risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine, set to take effect on 28 February 2019.
SAN DIEGO--(BUSINESS WIRE)--Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has approved updated Risk Evaluation and Mitigation Strategy ...
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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