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 starting today must put public health and drug safety at the center of new ...

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

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

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

The FDA is urging lawmakers to reauthorize a key user fee program that could expand access to over the counter medications, reducing barriers to treatment. At a recent hearing before the Senate ...

The Trump administration has presented a $6.8 billion budget request for the U.S. Food and Drug Administration (FDA) for the 2026 fiscal year. Commissioner Martin Makary highlighted the proposal to ...

Researchers Suggest User Fees Could Help FDA Ensure Food Safety The U.S. Food and Drug Administration already collects user fees from drug and medical device companies, as well as accreditation and ...

That would be a roughly 18.6% decrease from $3.6 billion in budget authority the FDA received in its 2024 fiscal year. The 2024 FDA budget also included about $3.3 billion in industry user fees. The ...

However, a food-related user fee program must be comprehensive to support the FDA’s Human Foods Program and, as envisioned here, to support additional authorities that the agency needs to ...