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FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-M...[ Price : $8.95]
Neumora Therapeutics says its Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder missed its primary end...[ Price : $8.95]
CDER approves 50 novel products in 2024, five less than the 55 products approved in 2023 and well above the 10-year rolling annual...[ Price : $8.95]
FDA alerts patients, caregivers, and healthcare providers to the potential for some Boston Scientific Accolade pacemakers to need ...[ Price : $8.95]
FDA approves Xcoverys Ensacove, an anaplastic lymphoma kinase inhibitor, to treat some non-small cell lung cancers.[ Price : $8.95]
FDA approves Humacytes Symvess for use with some extremity arterial injuries.[ Price : $8.95]
FDA recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to ...[ Price : $8.95]
FDA publishes an updated Global Unique Device Identification Database guidance.