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 ...

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

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.