FDA places a partial clinical hold on a Foghorn Therapeutics clinical study of FHD-609 in synovial sarcoma and SMARCB1-deleted tumors after the compan...
FDA clears a Maxtec 510(k) for the MaxO2 ME+p, an oxygen monitor with integrated pressure monitoring intended for continuous patient monitoring.
Avanos Medical recalls its Avanos Ballard Access Closed Suction System with Y-Manifold or Elbow Manifold after receiving complaints about cracked mani...
FDA extends by three months its review of a Daiichi Sankyo NDA resubmisson for quizartinib in combination with chemotherapy for treating adult patien...
CDER denies a 2021 citizen petition from Bausch Health that urged FDA not to approve any ANDA that cites Duobrii as the reference-listed drug unless t...
FDA approves Novartis Radioligand Therapy manufacturing facility in Millburn, NJ to manufacture prostate cancer therapy Pluvicto, which has been in sh...
New research on drug direct-to-consumer television advertising finds that viewers misinterpreted certain oncology clinical trial endpoint-related clai...
Federal Register notice: FDA issues a priority review voucher to Pharming Technologies that was related to its rare pediatric disease drug Joenja (len...
