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),...
FDA approves Nyxoahs Genio system, a hypoglossal nerve stimulation therapy for certain patients with moderate to severe obstructive sleep apnea.
FDA investigators cite seven GMP deficiencies from an inspection conducted last month at a Dr. Reddys drug manufacturing plant in India.
FDA accepts for review an Arvinas and Pfizer NDA for vepdegestrant, a first-in-class oral PROteolysis TArgeting Chimera therapy for treating estrogen ...
FDA approves PharmaThers KETARx (ketamine), indicated for use in treating surgical pain.
