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.
FDA orders significant labeling changes for Bluebird Bios Skysona (elivaldogene autotemcel), a gene therapy approved for treating early, active cerebr...
FDA says a nationwide shortage of sodium chloride 0.9% injection products has officially ended.
