Applied Therapeutics: FDA Stance Change For Advisory Panel Bodes Well For Review
Update on FDA's Applied Therapeutics, Inc. decision to remove advisory panel for govorestat review in treating galactosemia.
FierceBiotech4d
FDA scraps adcomm for Applied's rare disease drug ahead of November decision
After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided ...
FiercePharma6d
Intercept's liver med Ocaliva takes heat at FDA expert meeting, as hopes for full approval dim
Following a meeting with the FDA’s Gastrointestinal Drug Advisory Committee Friday, the future of Intercept’s rare liver ...
FDA advisers say phenylephrine doesn't work — so why do DayQuil, Theraflu and other popular decongestants still include it?
With cold and flu season approaching, here's the latest on where things stand with phenylephrine, which the FDA has deemed ...
FiercePharma11d
Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc
For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming. | Ahead of an advisory ...
Zevra Therapeutics' Drug Becomes First FDA-Approved Treatment For Ultra-Rare Neurodegenerative Disease
The FDA has approved Zevra Therapeutics' Miplyffa (arimoclomol) as the first treatment for neurological symptoms of ...
Health Affairs3d
Promoting Resilience Through The Advisory Committee On Immunization Practices
The U.S. vaccine policy landscape is broader and changing more rapidly than at any point in its modern history, and those ...
Applied Therapeutics Stock Soars As FDA Scraps Panel Meeting For Its Inherited Metabolic Disorder Drug
Applied Therapeutics stock rises as the FDA no longer requires an Advisory Committee meeting, keeping the Priority Review on ...
Company Statement on FDA Advisory Committee Meeting
While the FDA will take into consideration the committee’s vote, the vote is not binding upon the agency. The FDA will make the final decision and has assigned a Prescription Drug User Fee Act (PDUFA) ...
Medpage Today on MSN9d
Approved Liver Disease Drug Has No Clinical Benefit, FDA Panel Says
Obeticholic acid had been awarded accelerated approval by the FDA in May 2016 as a second-line treatment for PBC patients not ...
Iterum Therapeutics Provides Update on FDA Advisory Committee Discussion of Oral Sulopenem for the Treatment of uUTI in Adult Women
FDA Decision Expected by PDUFA Goal Date of October 25, 2024Potential to be First Oral Penem Approved in the U.S.DUBLIN and CHICAGO, Sept. 10, ...