FDA has announced that the agency will begin immediately reviewing all new clinical trials that include shipping American citizens’ living cells to “China and other hostile countries for genetic engineering and subsequent infusion” back into American patients.
Johnson & Johnson announced on June 15 new results from the phase II RedirecTT-1 study evaluating the investigational combination of Talvey (talquetamab-tgvs), the first U.S. FDA-approved GPRC5D-directed bispecific antibody, and Tecvayli (teclistamab-cqyv), the first FDA-approved BCMA-directed bispecific antibody.
FDA has approved Zusduri as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
FDA has approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma.
HHS Secretary Robert Kennedy Jr. asserted that under his leadership, FDA will “end the war” against alternative medicine.
FDA has approved Ibtrozi (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
Booth 10025 became an unlikely crowd magnet at the exhibit hall at the annual meeting of the American Society of Clinical Oncology that ended earlier this week.
Speaking at an FDA Roundtable on Cell and Gene Therapy, FDA Commissioner Marty Makary questioned the construct of “levels of evidence” as artificial and dogmatic, saying that n-of-1 “stories” can drive regulatory decisions.xxx:more“I think we can learn a lot from individual experiences,” Makary said at the roundtable discussion June 5. “We tend to talk in the lexicon of clinical medicine about Level 1, 2, and 3 evidence, and it’s become this sort of dogma that ‘we
FDA rolled out a generative artificial intelligence tool designed to help employees across the agency “work more efficiently.”
FDA approved the oral androgen receptor inhibitor Nubeqa (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer, which is also known as metastatic hormone-sensitive prostate cancer.
