Articles related to FDA

Enhertu, now FDA approved for HER2-positive solid tumors, shows a notable objective response rate across pivotal trials, providing a significant new option for patients with advanced disease stages.

Rejoyn represents a significant advancement in the treatment of major depressive disorder, requiring prescription use and integrating brain-training exercises developed by leading mental health experts.

The recent FDA approval of Lumicell’s breast cancer imaging system introduces a novel intraoperative tool that significantly enhances the precision of tumor resections, potentially reducing the need for subsequent corrective surgeries.

Zevtera® (ceftobiprole medocaril) provides a significant advancement in treating serious bacterial infections, demonstrating high efficacy against both MRSA and MSSA in recent phase 3 clinical trials.

Healthcare providers should be alert to symptoms of methanol poisoning, which can include vomiting, blurred vision, and seizures, particularly in patients who may have used recalled hand sanitizers containing methanol.

Explore the potential of Rejoyn™, a digital therapeutic now cleared by the FDA, which has shown to significantly reduce depressive symptoms in adults as an adjunct to traditional outpatient care, without any reported adverse events.