FDA tells Liquidia Corp. that its earlier user fee review action target date of 1/24 will be missed on the companys NDA for Yutrepia (treprostinil) in...
A Sheppard Mullin report describes several FDA issues that life sciences companies can expect to face in 2024.
FDA says it is looking for nine drug establishments to volunteer to test CDERs new QMM prototype assessment protocol.
Federal Register notice: FDA makes available a final guidance entitled Revising ANDA Labeling Following Revision of the RLD Labeling.
FDA releases the form FDA-483 with 11 observations from an inspection at the Deerfield, FL-based Hybrid Pharma outsourcing facility.
The CDER Office of Clinical Pharmacology launches a Web site to give healthcare professionals examples of drug interactions involving CYP enzymes and ...
FDA approves an expanded indication for Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) for treating pediatric patients aged one to 11 year...
FDA clears an Envisionit Deep AI 510(k) for its artificial intelligence (AI)-assisted chest x-ray device, Radify Triage, for triaging pneumothorax and...
