Merck says that on the recommendation of independent data monitoring committees, it is discontinuing a Keytruda lung cancer trial and a cutaneous squa...
Tandem Diabetes Care says it is recalling an Apple app used with its t:slim insulin pump and replacing it with updated software.
CDER creates a new internal Artificial Intelligence Council to oversee, coordinate, and consolidate all Center AI activities.
FDA grants Nuvectis Pharma an orphan drug designation for NXP800 and its use in treating ovarian, fallopian tube, and primary peritoneal cancers.
FDA approves a Renata Medical PMA for its Minima Growth Stent thats intended for treating congenital heart disease in infants and young children.
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 ...
Novartis says its Leqvio successfully lowered LDL cholesterol as a monotherapy in the Phase 3 V-MONO trial.
