FDA extends by three months its review of an Ascendis Pharma NDA for TransCon PTH (palopegteriparatide) due to the companys submission of additional i...
FDA approves Baxters expanded indication for parenteral (intravenous) nutritient Clinolipid (lipid injectable emulsion) for use in pediatric patients,...
Philips Respironics recalls (Class 1) its Trilogy Evo continuous ventilator devices due to a software issue that may cause a power malfunction.
Novo Nordisk says it will seek FDA approval by the end of the year for Mim8, its next-generation Factor 8a mimetic bispecific antibody for once-weekly...
FDA grants Merus a breakthrough therapy designation for petosemtamab for treating certain patients with recurrent or metastatic head and neck squamous...
FDA issues a warning for healthcare providers and consumers not to use Cue Healths Covid-19 tests due to the increased risk of false results.
FDA issues Eugia Pharma Specialties (an Aurobindo subsidiary) a seven-item Form-483 following a 5/3-concluded inspection at its sterile drug manufactu...
FDA accepts for priority review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment fo...
