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A Study of MK-8591 in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)
This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral therapy (ART) activity of MK-8591 monotherapy in ART-naive, human immunodeficiency...
FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies.
The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or postmarketing adverse event (AE) data sources.
An update on conbercept to treat wet age-related macular degeneration
Wet age-related macular degeneration (w-AMD) represents the main cause of vision loss in the elderly in the western countries. The important role displayed by vascular endothelial growth factor (VEGF) in the pathogenesis of this disease has been largely demonstrated.
Ixekizumab for the treatment of psoriasis: an update on new data since first approval
Areas covered: In this review, we summarize the latest clinical study results on ixekizumab. Long-term Phase III study data on efficacy and safety are now available for both plaque psoriasis and psoriatic arthritis.
BMS and 2seventy bio provide update on FDA review of sBLA for Abecma (idecabtagene vicleucel) in earlier lines of therapy for triple-class exposed relapsed or refractory multiple myeloma.
Bristol Myers Squibb and 2seventy bio, Inc. announced the FDA 's Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) based on results from the pivotal Phase III KarMMa-3 study