Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions like warm autoimmune hemolytic anemia, a life-threatening disease in ...

In 2007 the US Congress created the priority review voucher program to encourage the development of drugs for neglected diseases. Under the program, the developer of a drug that treats a neglected ...

Composition of Health Care Contact Days and Mortality Prediction Among Older Adult Clinical Trial Participants In this cross-sectional study, we used US Food and Drug Administration’s (FDA), European ...

A Prescription Drug User Fee Act target date of September 22, 2026 has been set for the application. The Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA ...

A Prescription Drug User Fee Act target date has been set for the third quarter of 2026. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License ...

Pfizer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Hympavzi hemophilia drug for two patient populations with significant medical need ...

A Prescription Drug User Fee Act date of May 10, 2026 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License ...

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A Prescription Drug User Fee Act date of April 30, 2026 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug ...