2 stories tagged "accelerated-approval"
FDA's new gene therapy draft guidance invites sponsors to lean on "platform knowledge" to streamline submissions, six months after the agency revoked Sarepta's AAVrh74 platform designation following three patient deaths.
Drugs & FDAThe FDA cleared bulevirtide for chronic hepatitis delta this week, six years after Europe started using it and three years after a U.S. application was turned down on manufacturing grounds. The wait is its own story.