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.
Novartis says that it will seek FDA approval of its investigational drug ianalumab after it met the primary endpoint in two Phase 3 trials for Sjgrens...
FDA accepts for priority review a GSK supplemental NDA for gepotidacin as an oral treatment for uncomplicated urogenital gonorrhoea in patients aged 1...
IO Biotech says its investigational cancer vaccine Cylembio (imsapepimut and etimupepimut, adjuvanted), combined with Mercks Keytruda (pembrolizumab),...
