HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

ACTIONS BY MONTH Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Apr-24 May-24 Jun-24 Jul-24 Aug-24 Sep-24 FY-2024 Approvals 57 51 53 56 52 48       […]

Docket Number: FDA-2024-D-1032 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA […]

For Immediate Release: May 03, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

Listen Dr. Roach: Welcome to “Q&A with FDA,” where we aim to answer some of the most frequently asked questions that we’ve received from the public. […]

On This Page Date: May 7 – 8, 2024 Day1: Tue, May 7 9:00 AM – 5:00 PM ET Day2: Wed, May 8 9:00 AM – […]

Rezdiffra (resmetirom) In conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with […]

This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been […]