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).

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, ...

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 ...

FDA designates MB-101 CAR T-cell therapy for glioblastoma, highlighting its potential in treating aggressive brain tumors ...

In an ongoing Phase 1 trial published in Nature Medicine, MB-101 was well-tolerated and 50% of patients achieved stable ...

Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and ...

Jeneen Interlandi, a domestic correspondent for Opinion and a staff writer at the magazine, writes frequently about public ...

Mustang Bio stock surged over 180% on Monday after the FDA granted its brain cancer drug candidate an orphan drug designation.