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...
Federal Register notice: FDA issues a priority review voucher to Pharming Technologies that was related to its rare pediatric disease drug Joenja (len...
FDA provides further clarification about a safety alert issued earlier this month that recommended against the use of certain surgical N95 respirators...
Federal Register notice: FDA makes available a draft guidance entitled Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.
FDA releases the form FDA-483 with 10 observations from a recent inspection at a Lupin drug manufacturing facility in Pithampur, India.
