FDA Roundup: April 9, 2024 [Yahoo! Finance]
DAIICHI SANKYO S/ADR (DSNKY)
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Source: Yahoo! Finance
On Friday, the FDA authorized for marketing MMI North America, Inc.'s Symani Surgical System, indicated for use during certain microsurgical procedures on small blood vessels and lymphatic ducts in adults. The system includes the use of a motion scaling function, which scales down the surgeon's movements. Microsurgery covers procedures involving the use of microscopes and small instruments to perform small-scale surgical techniques. The system is intended for use by trained physicians in the operating environments described in the device's labeling. On Friday, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. View full prescribing information for Enhertu Additional Resources: FDA Newsroom Media Contact: FDA Office of Media Affairs Consumer
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- Fight Colorectal Cancer Launches ChatCRC: An AI-Powered Chatbot Revolutionizing Colorectal Cancer Support [Yahoo! Finance]Yahoo! Finance
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) improved PFS in HER2-low and ultralow [Yahoo! Finance]Yahoo! Finance
- ENHERTU® Demonstrated Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in HR Positive, HER2 Low Metastatic Breast Cancer Following One or More Lines of Endocrine Therapy in DESTINY-Breast06 Phase 3 TrialBusiness Wire
- Germany's Scholz pledges support for pharmaceutical industry [Yahoo! Finance]Yahoo! Finance
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the US as first tumor-agnostic HER2-directed therapy for previously treated patients with metastatic HER2-positive solid tumors [Yahoo! Finance]Yahoo! Finance