Lexicon Pharmaceuticals says that after receiving recent FDA feedback it plans to resubmit its NDA for sotagliflozin oral tablets as an adjunct to ins...
Acadia Pharmaceuticals stops developing pimavanserin for treating negative symptoms of schizophrenia based on disappointing top-line results from a Ph...
Federal Register notice: FDA makes available a draft guidance entitled Early Alzheimers Disease: Developing Drugs for Treatment.
Federal Register notice: FDA sends to OMB an information collection extension on adverse experience reporting for licensed biologics.
Federal Register proposed rule: FDA proposes to revise the requirements for the content and format of labeling for approved or conditionally approved ...
Windstone Medical Packaging recalls its Local Lower Extremity Pack, In-House Ocular Pack and Closure Kit in response to Nurse Assists 2023 ongoing rec...
FDA sends Viatris/Mapi Pharma a complete response letter on the NDA for GA Depot 40 mg, a long-acting glatiramer acetate being investigated as a once-...
Abbott recalls its HeartMate Touch System (version 1.0.32) due to the risk of an unexpected pump stop or start.
