FDA CBER主任Peter Marks近日在再生医学联盟会议上透露，FDA即将调整CAR-T疗法的黑框警告内容。

研究结果如下： Belantamab mafodotin：Belantamab mafodotin（belamaf）是首个获美国食品药品监督管理局（Food and drug administration，FDA）批准的 BCMA 靶向 ADC，但曾因 3 期临床试验 DREAMM - 3 未达临床终点而退出美国市场。不过，后续研究带来了新希望。在 DREAMM - 7 试验中 ...

目前全球已有两款BCMA/CD3双抗获批上市，分别为强生的Tecvayli（teclistamab）和辉瑞的Elrexfio（elranatamab）。 美国FDA加速批准了 ...

FDA预计在2025年7月10日前对该申请做出 ... Linvoseltamab是一种旨在将多发性骨髓瘤细胞上的B细胞成熟抗原（BCMA）与表达CD3的T细胞桥接，以促进T细胞 ...

The US FDA has cleared Tecvayli (teclistamab ... It joins a number of other BCMA-directed therapies for multiple myeloma, including GSK's first-to-market antibody-drug conjugate Blenrep ...

Regeneron’s bid to join the market for BCMA-targeted bispecific antibodies for multiple myeloma is nearing a conclusion, with the FDA starting a priority review of its linvoseltamab drug candidate.

TransCon PTH是一种长效甲状旁腺激素（PTH）前药，旨在将HP患者的PTH恢复至生理水平，以解决HP导致的血钙含量降低、血液磷酸盐水平升高等问题。

The FDA has accepted the resubmitted BLA for linvoseltamab for patients with relapsed/refractory multiple myeloma.

What’s the plan?” he said. The FDA confirmed the cancellation in a statement sent to CNN on Thursday. “A planned March 13 meeting of the FDA’s Vaccines and Related Biological Products ...

In December, the FDA finalized a rule that updates the nutritional requirements a human food item must meet to claim on its packaging that it is “healthy.” That rule was published with an ...

It's an important meeting. What's the plan for flu vaccines this year," Dr. Paul Offit, a member of the FDA advisory committee and director of the Vaccine Education Center at Children's Hospital ...