Notable Approvals | Drugs

On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

In accordance with the Generic Drug User Fee Amendments (GDUFA), FDA consults with industry and the public to create an annual list of regulatory science initiatives on generic drugs. These priorities are discussed and developed in public meetings and workshops, resulting in several awarded projects

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 1/14/2026
Short Title (70 char) US Specialty Formulations LLC. Allentown, PA. 483 issued 1/14/2026
FEI Number 3010680515
Firm Name US Specialty Formulations LLC
Record Type 483
State PA
Establishment Type Outsou

Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products.

The DSB is composed of representatives from two FDA Centers and eight other federal government agencies, the Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Department of Defense.

CGMP/Finished Pharmaceuticals/Adulterated