Apr. 9
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
U.S. Food and Drug Administration
09 Apr, 2024, 15:31 ET
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