Mayo Clinic issued the following news release:. Mayo Clinic will have the first clinical 7- Tesla MRI scanner in North America that has been cleared by the U.S. Food and Drug Administration. Mayo Clinic will be the first medical center in North America to offer patients advanced diagnostic imaging using an MRI scanner with the strongest magnetic fi
Excluding specified items, adjusted diluted EPS from continuing operations was $0.66 in the third quarter, at the high end of the previous guidance range of $0.64 to $0.66. In September, Abbott received U.S. FDA approval for its FreeStyle Libre glucose monitoring system as a replacement1 for finger stick blood glucose monitoring. During the quarter
BioLife Solutions, Inc., the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media, today announced that its customer Kite Pharma, Inc., a wholly-owned subsidiary of Gilead Sciences, has received US FDA approval for Yescarta, the first CAR T-cell therapy for.
By a News Reporter-Staff News Editor at Genomics& Genetics Weekly Cerus Corporation announced that Rhode Island Blood Center received approval by the U.S. Food and Drug Administration on their Biologics License Application requesting allowance for interstate distribution of platelets that have been pathogen-reduced with the INTERCEPT Blood System
Oct. 20 Kite Pharma, bought by Gilead Sciences for $12 billion in August this year, has announced that the US Food and Drug Administration has granted regular approval to its cancer treatment Yescarta. The product was approve on a fast-track process. Because of the combination of this process and the innovativeness of the product there were fears
On 18 October the Food and Drug Administration approved the second gene-altering cancer treatment for patients with diffuse large B-cell lymphoma, the most common aggressive type of non-Hodgkin lymphoma, a blood cancer. The new therapy, Yescarta, is now approved only for adults who have had two or more failed chemotherapy regimens. Today is an impo
The U.S. Food and Drug Administration has approved Yescarta, a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor T cell therapy, is the second gene therapy approved by the FDA a
OptiScan Biomedical, which focuses on patient monitoring in the intensive care unit, scored an FDA nod for its bedside device that continuously monitors patients glucose levels. I look forward to implementing this technology as soon as possible, said Grant Bochicchio, M.D., chief of acute and critical care surgery at Washington University School of
Gilead Sciences jumped early Thursday after the Food and Drug Administration approved what is known as a CAR-T drug, dubbed Yescarta, to treat an aggressive form of Non-Hodgkin lymphoma. The approval follows two weeks after Gilead closed its acquisition of Kite Pharma, which developed the drug, and after Novartis` CAR-T drug was approved in late Au
The drug received a fast-track approval for the first-line treatment of NSCLC from the US FDA, but has since been knocked-back by the UKs cost-effectiveness watchdog NICE. Dr Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, said: With these findings from KEYNOTE-024, we con
Oct. 20 University of Chicago Medicine will be the first health system in the Chicago area to offer a newly approved gene therapy treatment for adults with cancer. The U.S. Food and Drug Administration approved it Wednesday. It's the second gene therapy treatment to be approved by the FDA, which gave the thumbs-up in late August to a similar trea
"Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases," FDA Commissioner Scott Gottlieb said in a statement late Wednesday. The FDA approved the first gene therapy against cancer in August, a leukemia treatment called Kymriah, made by Novartis. Yescarta was initially developed by.
The FDA`s Expanded Access Program provides a path to accessing devices for patients whom the treating physician believes may provide a benefit, but have not received FDA marketing approval. The surgical team, led by Jeffrey L. Port M.D., attending cardiothoracic surgeon at NewYork-Presbyterian/Weill Cornell Medical Center and professor of clinical.
BioLife Solutions, Inc., the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media, today announced that its customer Kite Pharma, Inc., a wholly-owned subsidiary of Gilead Sciences, has received US FDA approval for Yescarta, the first CAR T-cell therapy fo
Oct. 19 The Food and Drug Administration has approved a treatment that genetically alters patients' cells to attack cancer in fighting non-Hodgkin lymphoma. Mounzer Agha, director of the Lemieux Center for Blood Cancers at UPMC Hillman Cancer Center, on Thursday called the treatment a "paradigm shift" in cancer therapy. The treatment, called Yesc
The U.S. Food and Drug Administration approved a new form of cell-based gene therapy for adults with certain types of large B-cell lymphoma, marking only the second time a gene therapy has been approved for the disease. The FDA said diffuse large B-cell lymphoma is the most common type of non-Hodgkin's Lymphona in adults and there are approximately
Gilead Sciences, Inc. shares are trading higher by 80 cents at $80.81 in Thursday's session. After Wednesday's close, subsidiary Kite Pharma announced FDA approval for Yescarta, a gene-altering treatment for cancer. The stock has come hard off that level and so far found intraday support just under the upper-range of Wednesday's as $80.52 stands as
The U.S. Food and Drug Administration approved Wednesday Gilead Sciences, Inc.' s therapy for the treatment of non-Hodgkin's Lymphoma called YESCARTA. The FDA's approval of Yescarta shouldn't have come as a surprise, Morgan Stanley's Matthew Harrison said in a research report. Moreover, the list price of $373,000 did come in ahead of what the analy
IMPLANET, a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has received European regulatory clearance through the CE Mark to market the new JAZZ Passer. Following 510 marketing clearance from the FDA in September for the US market, Implanet has just received the CE Mark for its new JAZZ
-Kent Imaging, a leading provider of near infrared imaging solutions, announced today that the U.S. Food and Drug Administration has cleared their multispectral Medical Imaging Device. Adam Landsman, DPM, PhD, Chief of Division of Podiatric Surgery at the Cambridge Health Alliance. " Furthermore, because the data can be collected in less than a sec
Nexus Pharmaceuticals announced today the immediate availability in the United States of Procainamide HCL Injection, USP. "The introduction of Procainamide HCL Injection, USP further illustrates Nexus Pharmaceuticals' commitment to meeting market needs and shortages in the short term, while broadening the availability of effective generic produc
WASHINGTON- Novo Nordisk said that the Endocrinologic and Metabolic Drugs Advisory Committee or EMDAC of the US Food and Drug Administration voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. Based on the data included in the New Drug Application for semaglutide, the FDA aske
PolarityTE, Inc. today announced that multiple value analysis committees have approved SkinTE? for use at their respective medical institutions as the Company continues its commercialization efforts and manufacturing scale-up. About SkinTE? and FDA Tissue Establishment Registration SkinTE? is marketed and regulated by the U.S. Food and Drug
Oct. 19 University of Chicago Medicine will be the first health system in the Chicago area to offer a newly approved gene therapy treatment for adults with cancer. The U.S. Food and Drug Administration approved it Wednesday. It's the second gene therapy treatment to be approved by the FDA, which gave the thumbs-up in late August to a similar trea