Novartis says its Leqvio successfully lowered LDL cholesterol as a monotherapy in the Phase 3 V-MONO trial.
FDA warns three companies illegally marketing CPAP cleaning/sanitizing devices in the U.S.
FDA accepts for priority review a Soleno Therapeutics NDA for DCCR (diazoxide choline) for treating Prader-Willi syndrome (PWS) in individuals aged fo...
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 ...
