If stakeholders seize this opportunity, we can meaningfully improve access while maintaining safety. Consider the case of patient WB, a 79-year-old male with recurrent diffuse large B cell lymphoma.
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(RTTNews) - Organon (OGN) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON (etonogestrel implant). NEXPLANON is ...
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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 review comes a year after a Supreme Court decision preserved access to mifepristone. (Photo by Sarah Silbiger/Getty Images) It was only about a year ago that the biopharma industry hailed a ...
The update now reduces the frequency of liver function monitoring to every 3 months from the onset of treatment. The Food and Drug Administration (FDA) has updated the risk evaluation and mitigation ...
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 ...
In a surprising announcement, the U.S. Department of Education’s Office of Safe and Supportive Schools announced the closure of the Readiness and Emergency Management for Schools (REMS) Technical ...
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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 FDA has eliminated Risk Evaluation and Mitigation Strategies for all currently approved BCMA- and CD19-directed autologous CAR-T cell immunotherapies, determining that the safety program is no ...
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