FDA grants full approval to GSKs Jemperli (dostarlimab-gxly) for certain adult patients with mismatch repair deficient (dMMR) recurrent or advanced en...
Federal Register notice: FDA issues an order debarring Hassan Tahsildar for two years from providing services to a person that has an approved or pend...
CBER director Peter Marks says the Center is recruiting 125 new staff to work on cell and gene therapies during a transitional 2023.
FDA grants an emergency use authorization for a BD molecular test that differentiates between Covid-19, the flu, and RSV.
FDA medical reviewers raise concerns about GlaxoSmithKlines proposed trials of Jemperli to support a future BLA accelerated approval for some rectal c...
Two medical device associations suggest ways to improve an FDA draft guidance on the Voluntary Malfunction Summary Reporting program created under MDU...
CDER describes a research study using flow microscopy and convolutional neural networks to monitor changes in product quality attributes.
FDA clears a DiA Imaging Analysis 510(k) for its LVivo IQS, a new artificial intelligence-based vendor-neutral software intended to help users in acqu...
