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 ...

Pharmalittle: We’re reading about FDA morale, a U.S.-Swiss trade deal on pharma levies, and more A regulatory shift is raising questions about future partnerships between U.S. and Chinese drugmakers ...

The Pay.gov feature is available on the FDA website upon receipt of an invoice or after completing the User Fee Cover Sheet and generating the user fee ID number. Secure electronic payments to FDA can ...

The FDA has granted priority review to an application for Revuforj for the treatment of relapsed or refractory mutant NPM1 acute myeloid leukemia.

Moreover, it can be expected that this program will feature prominently in Prescription Drug User Fee Amendments (“PDUFA”) user fee negotiations that are expected to begin later this year.

FDA accelerates approval of datopotamab deruxtecan for advanced EGFR-mutated NSCLC, offering new hope for previously treated patients.

Even the user fee system — critical to funding timely drug reviews and a source of government revenue — has been impacted by the reduction in force.