This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape.

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 ...

The long-awaited GOP proposal moves Harrisburg’s marijuana talks forward, but the issue still divides the Pa. Senate.

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

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

GUANGZHOU, China I July 16, 2025 I Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...

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 ...