Articles related to DEVICE/DRUG APPROVALS

The FDA-approved Rejoyn app, designed for major depressive disorder, combines therapeutic exercises and emotional regulation training to complement antidepressant therapy, showing significant improvement in clinical trials.

Explore the FDA-cleared Modius Stress, offering groundbreaking ease in managing generalized anxiety with daily 30-minute sessions, showing significant reductions in GAD-7 scores in international clinical trials.

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.