Draeger recalls (Class 1) its SafeStar and TwinStar breathing filters due to a risk of misleading carbon dioxide readings.
AI expert Brooke Moy says FDA may have felt pressured to move too quickly to implement its Elsa internal AI tool without planning for sufficient human...
FDA approves an Insmed NDA for Brinsupri (brensocatib) tablets as the first treatment for non-cystic fibrosis bronchiectasis in patients aged 12 and o...
Merck announces that the combination of Keytruda (pembrolizumab) and Pfizers Padcev (enfortumab vedotin-ejfv), given before and after surgery, signifi...
A MedDevice Online column says manufacturers can often avoid an FDA Warning Letter by providing an urgent and accountable full response to a form FDA-...
The Guardian reports that the emergency use authorization for Pfizers Covid-19 vaccine for children under five may not be renewed by FDA this fall.
Vinay Prasad returns as CBER head at FDA commissioner Marty Makarys request after gaining White House approval.
