FDA accepts for priority review a SpringWorks Therapeutics NDA for mirdametinib, an investigational MEK inhibitor for treating pediatric and adult pat...
Liveyon founder and CEO John Kosolcharoen pleads guilty to a felony charge of introducing an unapproved new stem cell product into interstate commerce...
FDA publishes a guidance describing and clarifying several aspects of the Voluntary Malfunction Summary Reporting program.
Researchers call on FDA to require postmarketing studies for breakthrough therapy-designated drugs studied with surrogate endpoints for traditional ap...
Abbott Diabetes Care begins a Class 1 recall (device correction) of its FreeStyle Libre 3 sensors based on users reporting situations where they were ...
An FDA inspection of a Global Calcium manufacturing facility in Hosur, India leads to a six-observation Form FDA-483 that cites significant GMP violat...
Federal Register notice: FDA announces a 10/30 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on patient-cen...
Three stakeholders ask FDA to modify a draft guidance on the agencys platform technology designation guidance.
