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.

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 ...

The FDA recently announced it had eliminated the Risk Evaluation and Mitigation Strategies safety program in place for all BCMA- and CD19-directed autologous chimeric antigen receptor T-cell ...

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 ...

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 ...

Using chimeric antigen receptor (CAR) T-cell therapies for blood cancer should be less burdensome following labeling updates from the FDA. In a June 26 letter to Janssen explaining the move, the ...

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 ...

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: ...