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 ...
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 ...
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 ...
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.
FiercePharma10d
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 ...
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 ...
FDA AdComm to discuss IceCure's ProSense on Nov. 7
IceCure Medical (NASDAQ:ICCM) said an FDA advisory committee will meet on Nov. 7 to discuss its De Novo Classification ...
FDA Approves Zevra's Miplyffa for Niemann-Pick Disease Type C
Zevra Therapeutics has won Food and Drug Administration approval of Miplyffa for Niemann-Pick disease type C, making it the first drug cleared in the U.S. for the rare neurodegenerative disorder.
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 ...
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 ...
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, ...
FDA finds some 'dairy-free' chocolate products contain milk
Consumers should be aware that some chocolate labeled as "dairy-free" actually contains milk, the U.S. Food and Drug ...