FDA approves an Alnylam Pharmaceuticals NDA for Amvuttra (vutrisiran), an RNAi therapeutic administered by subcutaneous injection once every three months for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis.
Troutman Pepper attorneys discuss a new FDA draft guidance giving sponsors information on presenting diversity plans to enroll under-represented populations in drug and medical device trials.
FDA commissioner Robert Califf says a total revamp of the drug accelerated approval program is not needed to answer criticism following a number of drug indications being withdrawn because companies were unable to generate confirmatory data.
FDA says it is working with the Organization of Economic Cooperation and Development on a “whole-of-governments” approach to fighting illicit medical products.
An FDA advisory committee votes unanimously (22 to 0) to recommend the agency grant Moderna an emergency use authorization for its Covid-19 vaccine in children aged six months to 17 years.