Stoke Therapeutics and the FDA were unable to reach agreement on an expedited submission for the company’s severe epilepsy ...

By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it ...

With a new administration bringing in a sweeping change in ideology and a heavy focus on health, the food industry lived ...

The Priority Review Voucher (PRV) program is designed to incentivize rare disease drug development.

Co-founded by Jennifer Doudna and Fyodor Urnov, the company intends to simultaneously develop many gene editing treatments for rare conditions by using the agency’s “plausible mechanism” pathway.

PDS Biotech Submits Amended Protocol for Phase 3 VERSATILE-003 TrialConstructive Type C Meeting Provides Potential Pathway to Accelerated ...