The U.S. Food and Drug Administration today approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in the survival motor neuron 1 (SMN1) gene. Itvisma is an adeno-associated virus (AAV) vector-based gene therapy. “Today’s approval shows the...
The U.S. Food and Drug Administration today granted approval for Avance (acellular nerve allograft-arwx) in surgical implantation. Avance is a peripheral nerve scaffold approved for sensory nerve discontinuities (≤25mm) (breaks in the pathway of sensory nerves) in adults and pediatric patients aged one month and older. Under the Accelerated Approval pathway, Avance...
The U.S. Food and Drug Administration today approved a new indication for Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy in the U.S. for treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines of therapy. Breyanzi is a chimeric antigen receptor CAR...
What if a diabetes drug could also lower the risk of dementia?
GLP-1 medications are widely used to treat type 2 diabetes and support weight loss. But new research suggests they may also help protect the brain. A large analysis published in JAMA Neurology looked at whether certain diabetes drugs in the GLP-1 class are linked to a lower risk of dementia—and the results are raising important questions about brain health and aging.
The U.S. Food and Drug Administration today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety. Developed by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot will evaluate a new,...
The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric...