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...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Jemperli (dostarlimab-gxly), i...
FDA tells Moderna that it needs a couple more weeks to complete the review of its BLA for mRNA-1345, the companys investigational respiratory syncytia...
