Bristol-Myers Squibb recalls one lot of its blood thinner Eliquis (apixaban) 5 mg tablets after a customer complaint said a bottle labeled as Eliquis ...
FDA clears an Etiometry 510(k) for the Inadequate Oxygen Delivery Index for monitoring intensive care unit patients aged 12 years or younger.
FDA releases its latest batch of Warning Letters that includes A-S Medication Solutions, Belmora and The See Clear Company.
Boehringer Ingelheim asks FDA not to approve NDAs for a fixed-dose, triple-combination, inhaled drug product to treat COPD unless the product meets Co...
FDA clears an I-Bone 510(k) for the iFuse-3D Implant, the first-ever 3D-printed titanium implant for use in the sacroiliac joint.
FDA clears a Techlab 510(k) for its E. Histolytica Quik Chek, a rapid diagnostic test for detecting pathogenic E. histolytica that does not cross reac...
FDA clears a GenMark Diagnostics 510(k) for both its ePlex instrument and Respiratory Pathogen Panel.
A U.S. Supreme Court ruling means biosimilar products are likely to launch faster due to an earlier marketing advance notice option.