SILVER SPRING, Md., April 9, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
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.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
The global industrial automation market in life sciences industry size is estimated to grow by USD 5.06 bn from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of 11.4% during the forecast period. ...
Gilead Sciences, Inc. , following the recent acquisition of CymaBay Therapeutics, Inc., today announced interim results from the ongoing ASSURE study demonstrating treatment with seladelpar, an investigational PPAR delta agonist, led to improvements...
Mirum Pharmaceuticals, Inc. today announced data presented during the 56th European Society for Paediatric, Gastroenterology, Hepatology, and Nutrition (ESPGHAN) Annual Meeting which took place this week in Milan, Italy. Data from LIVMARLI®...
After tens of thousands of NYC children were turned away from "Summer Rising," New York City's popular, free summer enrichment program, Brains & Motion launched a campaign offering camps at NYU for a small fraction of the up-to-$1400 per week price...
Gotion High-tech hosted its 13th Technology Conference on May 17, unveiling its new products and new technology, including 5C ultra-fast charging G-Current battery ready for immediate mass production, high-nickel NCM cylindrical Stellary battery and...