FDA accepts for review an Alexion Pharmaceuticals supplemental BLA for the use of Soliris (eculizumab) in treating certain patients with neuromyelitis...
ICU Medical begins a Class 1 recall of one lot of ChemoLock Vial Spikes, 20mm due to the potential for plastic particles to break off the protective c...
FDA approves a Biotronik PMA for its Orsiro drug-eluting stent system.
FDA commissioner Scott Gottlieb and CDER director Janet Woodcock defend the agencys oversight of the generic drug industry to quash any doubt that gen...
FDA warns American Preclinical Services about violations in its conduct of several nonclinical medical device laboratory services.
FDA clears an Intuitive Surgical 510(k) for the Ion endoluminal system to enable minimally invasive biopsies in the peripheral lung.
FDA releases a draft guidance on Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products.
FDA clears an Axilum Robotics 510(k) for the TMS-Cobot TS MV, indicated for the spatial positioning and orientation of the MagVenture Transcranial Mag...