Sprout Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its ...

Through its recently unveiled Priority Voucher program, the FDA seeks to accelerate the review process for companies that ...

The FDA has accepted for Priority Review the BLA for tividenofusp alfa for the treatment of Hunter syndrome, also known as MPS II.

Priority review vouchers are one tool in the policy incentives toolbox, and have proven to be of interest to developers and stakeholders as a means of encouraging innovation in areas of unmet ...

The FDA has granted Priority Review to TAR-200 for the treatment of patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors ...

Pfizer and BioNTech said Friday the FDA has granted priority review designation to their application for approval of their Covid-19 vaccine, and an FDA official said the decision will come within ...

To address this, we propose a new priority review voucher program to incentivize competition in limited-competition, small molecule generics markets. Specifically, ...

FDA grants Priority Review to SpringWorks Therapeutics’ New Drug Application for mirdametinib for the treatment of adults and children with NF1-PN. News release. SpringWorks.

The value of priority review vouchers, which drugmakers can use to expedite U.S. FDA review of their products, seems to be dwindling.Kyowa Hakko Kirin and Ultragenyx Pharmaceutical recently sold a ...