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 ...

In an interview with Targeted Oncology, Frederick L. Locke, MD, discussed how the elimination of the REMS program for CAR T-cell therapy came about and what effects he hopes this will have on patient ...

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 ...

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 ...

The US Food and Drug Administration (FDA) announced that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric ...

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 ...

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 ...

June 27 (Reuters) - (This June 27 story has been corrected to reflect that Bristol Myers owns full rights to therapy Abecma in paragraph 4. The error had also ...

FDA-approved updates for Breyanzi and Abecma reduce patient monitoring and eliminate REMS, enhancing access to CAR T-cell therapies. Labeling changes reflect increased regulatory confidence in the ...