According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

The U.S. FDA has accepted a Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab).

FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.

Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...

U.S. Rep. Bob Latta, R-Bowing Green; Rep. Diana DeGette, D-Colorado; Rep. Dan Crenshaw, R-Texas; and Rep. Debbie Dingell, ...

The EU approves belantamab mafodotin combinations, enhancing treatment options for relapsed multiple myeloma patients with ...

MENOPAUSAL THERAPY IN FOCUS — The FDA will hold a panel discussion Thursday on hormone therapy for menopausal women, a pet ...

Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...

(Alliance News) - GSK PLC on Wednesday said the US Food & Drug Administration has extended the review period for Blenrep combinations in relapsed/refractory multiple myeloma after an advisory ...

GoodRx will pay $25 million to settle claims it shared users’ sensitive data with third parties like Meta and Google without ...