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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 ...

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 ...

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 ...

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 ...

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 ...

There is enough experience with the first wave of autologous CAR-T therapies targeting CD19 and BCMA to allow strict rules ensuring their safe use to be relaxed, according to the FDA. The US regulator ...

When CAR T-therapies first reached the market, they came with warnings and monitoring requirements to protect patients — for good reason. Engineering a patient’s own immune cells into targeted cancer ...

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 ...