FDA approves a Renata Medical PMA for its Minima Growth Stent thats intended for treating congenital heart disease in infants and young children.
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 determines that Exela Pharma Sciences fentanyl citrate injections, equivalent to 2.5mg/50mL and 5mg/100mL (EQ 0.05 mg bas...
Federal Register notice: FDA announces that it issued Mirum Pharmaceuticals a priority review voucher for its approved rare pediatric disease product ...
