FDAEMAFDAneurodegenerative/neuromuscular disordersrare diseasesRoche DISCOVERY™ ULTRA System
… and EMA, and many more are in clinical phase I-III trials. The FDA has issued recommendations to generate nonclinical biodistribut…
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Articles mentioning FDA
90 articles · page 7 of 8FDAtarlatamabMayo Clinic Rochestersmall cell lung cancerplatinum-based chemotherapy
…Background In May 2024, the FDA approved tarlatamab, a Delta-like ligand (DLL3)/CD3-targeted bi…
FDACAR-TFDA-approved
…t tool for MAb specificity that have been recommended in recent FDA guidance.Methods We developed a cell-based protein array, the M…
FDASanyou Biopharmaceuticals Laboratory Animal Ethics Committeemirvetuximab soravtansinegemcitabineexatecanplatinum-resistant ovarian cancerrecurrent diseaseepithelial ovarian cancersClone 65SKOV3
…tant setting, where treatment options remain limited. While the FDA has approved mirvetuximab soravtansine for platinum-resistant o…
Food and Drug AdministrationFDAFDAlemborexantbuprenorphineVirginia Commonwealth University Institutional Review Boardopioid use disorderinsomniaBUPOUD
…treatment options for this patient population. Lemborexant, the Food and Drug Administration (FDA)-approved dual orexin receptor antagonist for the treatmen…
FDAUS Food and Drug Administrationpublic insurerscancer drugs
…In the past three decades, the US Food and Drug Administration (FDA) has increasingly relied on surrogate endpoints (eg, disease-fr…
NICEFDArheumatoid arthritisrituximabobinutuzumabnon-Hodgkin’s lymphomalupus nephritis
…cell depleting agent. Its effectiveness was obvious and in 2006 NICE approved it for use in rheumatoid arthritis.Working with other …
MedicareFDACenters for Medicare & Medicaid Servicesthyroid cancerMetforminglyburideexenatidelixisenatideTCmalignant neoplasm of thyroid gland
…tiation.29 When estimating the risk of cancer outcomes in older Medicare patients, censoring those who died before hypothetically experi…
FDAIRB-approvalintractable seizuresOra-Sweet SFEpidiolexEpidiolex®NCT04749628CBD
…S, an oral cannabidiol solution, Epidiolex®, is approved by the FDA for the treatment of intractable seizures. We conducted an off-…
Food and Drug AdministrationFDAAlzheimer’s diseaseLecanemabLeqembi
…the approval of a weekly subcutaneous injectable version by the Food and Drug Administration (FDA).…
FDAskin cancerfoto-finder mole-analyzer pro
…tegrating AI-enabled technologies within a clinical setting.The FDA has not approved any medical advice or algorithms based on AI i…