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

(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 ...

College Station residents will have the opportunity to comment on the proposed budget for 2025-26 during a public hearing ...

Aldeyra Therapeutics (NASDAQ:ALDX) announced on Thursday that the U.S. Food and Drug Administration (FDA) accepted for review ...

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

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

The FDA’s mission is to protect public health. PIRG asked: "The prescription drug user fee reauthorization (PDUFA) process ...

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

The FDA has set a target action date of April 28, 2026, for the application under the Prescription Drug User Fee Act (PDUFA).

The Bureau of Land Management on July 7 began charging standard amenity fees at select special recreation management areas managed by the Colorado River Valley and Kremmling Field Offices. The agency ...