accelerated-approval
2 stories tagged "accelerated-approval"
Drugs & FDA
FDA's New Gene Therapy Shortcut Leans on 'Platform Knowledge.' Six Months Ago, They Revoked Sarepta's After Three Patient Deaths.
FDA's new gene therapy draft guidance invites sponsors to lean on "platform knowledge" to streamline submissions, six months after the agency revoked Sarepta's AAVrh74 platform designation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 & FDAHepatitis Delta Has Waited Forty-Nine Years for a Drug. The FDA Made American Patients Wait Three Extra.
The 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.