Makary tells Senate panel he plans to review FDA job cuts
FDA nominee Martin Makary was asked about abortion drugs, vaccine panels during a Senate hearing on his bid to lead the ...
C&EN2d
Kennedy orders FDA to review food ingredient loophole
US Health and Human Services secretary Robert F. Kennedy Jr. directs the Food and Drug Administration to explore revamping ...
JD Supra12d
FDA Drug Review Threatened by a Government Shutdown
The Food and Drug Administration (FDA) is not likely to continue to review and approve human drugs or medical devices if the federal government shuts down in March The federal government is ...
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Zevra sells priority review voucher for $150m to support drug launches
Zevra has sold its US Food and Drug Administration (FDA) priority review voucher (PRV ... sale to support the commercial launches of Miplyffa and the company’s urea cycle disorder drug Olpruva, which ...
pharmaphorum2d
FDA starts review of first bronchiectasis drug candidate
The FDA has started a priority review of Insmed's brensocatib ... the walls of the airways become thickened and damaged as a result of a cycle of inflammation and infections.
Cytokinetics says FDA does not plan advisory committee meeting for aficamten NDA
In a regulatory filing, Cytokinetics (CYTK) disclosed that at upcoming investor conferences, the company will be providing, and is hereby ...
Yahoo Finance24d
FDA to review Sanofi and Regeneron’s Dupixent sBLA for bullous pemphigoid
The US Food and Drug Administration (FDA) has accepted a supplemental biologics licence application (sBLA) for priority review, with a decision expected by 20 June 2025. If approved, Dupixent ...