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 ...

FDA grants priority review to TAR-200, which demonstrated an 82% complete response in high-risk bladder cancer unresponsive ...

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 ...

Priority review vouchers. The program is called the Priority Review Voucher Program for Neglected Diseases. When it was created, it covered specific diseases — among them, leprosy, malaria, and ...

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