This makes China the third country, after the United States and Russia, with vaccines available for use to combat the deadly infectious disease, the China Food and Drug Administration said. The vaccine improves China's ability to prevent and control major public health threats and provides a new means for China to handle global disease epidemics ef
Drugmaker GlaxoSmithKline said the Food and Drug Administration approved it late Friday. Studies paid for by Glaxo found it prevents shingles in about 90 per cent of people. Merck' s is about 50 per cent effective. The U.S. Centers for Disease Control and Prevention, though, recommends vaccination for those 60 or older, partly because it loses effe
Oct. 21 GlaxoSmithKline's new shingles vaccine, Shingrix, was approved Friday by the Food and Drug Administration, a potential $1 billion- a-year drug to prevent the shingles virus in adults 50 and older. The final step will be for the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices to sign off for the us
GlaxoSmithKline issued the following news release:. GlaxoSmithKline plc today announced that the US Food and Drug Administration has approved Shingrix for the prevention of shingles in adults aged 50 years and older. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said: "Shingrix represents a significant scientific...
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
A new, more effective vaccine to prevent painful shingles has been approved by U.S. regulators. Drugmaker GlaxoSmithKline said the Food and Drug Administration approved it late Friday. The move provides a second option to Merck's shingles vaccine, which has been sold for more about a decade. Shingles is caused by the chickenpox virus and causes a p
Agenus Inc., an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that the US Food and Drug Administration granted marketing authorization to GlaxoSmithKline's herpes zoster vaccine, SHINGRIX, containing Agenus' proprietary immune adjuvant QS-21 Stimulon . SHINGRIX is indicated for...
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
Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration has approved SIMPONI ARIA , the only fully-human anti-tumor necrosis factor- alpha therapy administered via a 30- minute infusion, for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis. Today's approvals follow the first FDA
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