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Latest News from FDA News
ST. HELIER, Jersey, Aug. 21, 2014 /PRNewswire/ -- Novocure, a commercial stage oncology company, announced today that it has submitted the registration dossier for Pre-Market Approval (PMA) of the NovoTTF-100A System to treat recurrent glioblastoma to the Japanese Pharmaceutical and Me...
-- Japanese Society of Neuro-Oncology calls for rapid approval by the Japanese Ministry of Health and Welfare (MHLW)
ENGLEWOOD, Colo., Aug. 21, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a delay in the data analysis of the STEP Study due to the discovery by the independent Clinical Research Organization (CRO) that the study drug (both AmpionTM and the placebo) w...
CHESTERBROOK, Pa., Aug. 21, 2014 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced positive results from a randomized, double-blind Phase 2a study of collagenase clostridium histolyticum (or CCH) for the treatment of e...
New Amsterdam Sciences (NAS), an emerging bioscience company, announced today that while advancing to phase1 clinical trials it will continue its commitment for further research with renowned biochemist and research scientist Dr. Jacob Finkelstein of the University of Rochester Medical...
SAN JOSE, Calif., Aug. 21, 2014 /PRNewswire/ -- SI-BONE, Inc. (San Jose, California), a medical device company that pioneered the use of the iFuse Implant System,® a minimally invasive surgical (MIS) device indicated for fusion of the sacroiliac (SI) joint, announced that Priority Heal...
ANDOVER, Mass., Aug. 21, 2014 /PRNewswire/ -- Royal Philips (NYSE: PHG AEX: PHIA) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its precision planning application for Transcatheter Aortic-Valve Implantation (TAVI) treatments. Thro...
HOUSTON, Aug. 21, 2014 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ:CYBX) today announced results for the quarter ended July 25, 2014. 
LAUSANNE, Switzerland, August 21, 2014 /PRNewswire/ --
LAUSANNE, Switzerland, August 21, 2014 /PRNewswire/ --
Acceleware® Ltd. ("Acceleware" or the "Company") (TSX VENTURE: AXE), a leading developer of high performance computing applications, today announced results for the three and six months ended June 30, 2014 (all figures are in Canadian dollars unless otherwise noted). During the second ...
Acceleware® Ltd. ("Acceleware" or the "Company") (TSX VENTURE:AXE), a leading developer of high performance computing applications, today announced results for the three and six months ended June 30, 2014 (all figures are in Canadian dollars unless otherwise noted). During the second q...
LONDON, Aug. 20, 2014 /PRNewswire/ -- GlaxoSmithKline plc today announced that the FDA has approved Arnuity™ Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged...
HORSHOLM, Denmark, Aug. 20, 2014 /PRNewswire/ --
Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) today announced that it has filed an Investigational New Drug Application (IND) with the Division of Medical Imaging Products of the US Food and Drug Administration (FDA) to enable the initiation of a phase 1 study of AEOL 10150 in healthy hum...
 
LONDON, Aug. 20, 2014 /PRNewswire/ -- Reportbuyer.com has added a new market research report:Global Cardiac Defibrillators Industryhttps://www.reportbuyer.com/product/98394/Global-Cardiac-Defibrillators-Industry.html
ORLANDO, Fla., Aug. 20, 2014 /PRNewswire/ -- Cardiovascular Interventions (CVI) offers a state-of-the-art total cardiac health facility and staff. Founded by Dr. Pradip Jamnadas, who recently received recognition as a "Top Doc" in Central Florida by Castle Connolly Medical Ltd., the pr...
NEW YORK, Aug. 20, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:The Worldwide Market for Infusion Pumps http://www.reportlinker.com/p02051944/The-Worldwide-Market-for-Infusion-Pumps.html
EDEN PRAIRIE, Minn., Aug. 20, 2014 /PRNewswire/ -- Celleration, Inc., a privately held medical device company focused on developing and commercializing therapeutic ultrasound healing technologies to treat wounds, announced today they received FDA clearance for their next generation Ult...
TUCSON, Ariz., Aug. 20, 2014 /PRNewswire/ -- Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, today announced that its VENTANA System for Primary Diagnosis1 has been CE marked in the European Union for routine pathology, including primary diagnosis with human tissu...
-- New CE mark in the European Union extends application to routine pathology including primary diagnosis with human tissue specimens
LYNDHURST, N.J., Aug. 20, 2014 /PRNewswire/ -- Amerigen Pharmaceuticals Ltd. announces that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese FDA (CFDA) approval and has subsequently launched its generic Mecobalamin 0.5 mg Tablets into the China dom...
NEW YORK, Aug. 20, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:Global Feminine Hygiene Products Industry http://www.reportlinker.com/p01374691/Global-Feminine-Hygiene-Products-Industry.html
NEW YORK, August 20, 2014 /PRNewswire/ --
LOS ANGELES and NEW YORK, Aug. 20, 2014 /PRNewswire/ -- The Hollywood community is once again uniting to support Stand Up To Cancer (SU2C), a program of the Entertainment Industry Foundation (EIF), which will stage its fourth biennial fundraising telecast Friday, September 5 (8:00 – 9:...
Aurotech Inc., a leading-edge IT and e-discovery consulting firm, today announced that it has joined Exterro's partner program to deliver full-spectrum e-discovery software to its clients. Aurotech now delivers full services around Exterro's comprehensive e-discovery software suite tru...
NEW YORK, August 20, 2014 /PRNewswire/ --
IRVINE, Calif., Aug. 20, 2014 /PRNewswire/ -- Renowned beauty expert and makeup artist to the stars Julianne Kaye is partnering with Allergan, the makers of ACZONE® (dapsone) Gel 5%, the No. 1 prescribed retinoid-free acne brand in the U.S., to offer expert skincare and makeup tips in ...
Atossa Genetics Inc. (NASDAQ: ATOS) today announced that it has submitted additional information to the U.S. Food and Drug Administration in response to the FDA's February 21, 2014 request. The information was provided in support of Atossa's 510(k) submission for the ForeCYTE Breast As...
BioLargo, Inc. (OTCQB: BLGO) will present at the Rodman & Renshaw 16th Annual Global Investment Conference on Tuesday, September 9th at the New York Palace Hotel. Dennis Calvert, BioLargo's president, is scheduled to present at 2:55 p.m. ET.
ENGLEWOOD, Colo., Aug. 20, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that in response to requests from patients and physicians, the company has performed an analysis of the available data from both portions of the study. On October 7, 2013, follo...
LOS ANGELES, Aug. 20, 2014 /PRNewswire/ -- California Cryobank (CCB), a global leader in reproductive tissue donor services and storage and stem cell banking, announced today that it has been acquired by equity investors Longitude Venture Partners II, L.P. ("Longitude") and NovaQuest P...
SOUTHAMPTON, England, August 20, 2014 /PRNewswire/ --
SOUTHAMPTON, England, August 20, 2014 /PRNewswire/ --
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and EMA respectively) for the indication expansion of its in-house developed antiepileptic drug Fycompa (generic...