Le Lézard

News by subject: FDA

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2 july 2015

09:00
WASHINGTON, July 2, 2015 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a HETLIOZ® patent, number 9,060,995 ('995 patent), is now listed in the U.S. Food and Drug Administration publication Approved Drug...


1 july 2015

10:00
WHIPPANY, N.J., July 1, 2015 /PRNewswire/ -- Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved the use of transvaginal ultrasound (TVU) as an alternate confirmation test for Essure® permanent birth...

08:17
CAMBRIDGE, Mass., July 1, 2015 /PRNewswire/ -- MX Orthopedics, Corp. (MXO), a leader in superelastic technologies for orthopedic implants, announces the recent FDA clearance (K143622) of its patent-pending dynaMXtm Compression Staple featuring...

06:50
MUMBAI, July 1, 2015 /PRNewswire/ -- Accutest Laboratories recently completed a first-to-file study for the fixed dose combination of Memantine 28 mg ER and Donepezil hydrochloride 10 mg capsule in a record setting time of 5 days. This included...


30 june 2015

16:10
BUENA, N.J., June 30, 2015 /PRNewswire/ -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has submitted its fifth abbreviated new drug application (ANDA) to the U.S. Food and...

11:59
SAN JOSE, Calif., June 30, 2015 /PRNewswire/ -- Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today that the U.S. Food and Drug Administration...

10:11
TEL-AVIV, Israel, June 30, 2015 /PRNewswire/ -- BioLight Life Sciences Investments Ltd. (OTC: BLGTY, TASE:BOLT), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that...

09:18
JERUSALEM, June 30, 2015 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical Company focused on the development of oral drug delivery systems, announced today that the first patient has...

08:00
NEW YORK, June 30, 2015 /PRNewswire/ -- Centinel Spine, Inc., (Centinel Spine) the pioneer of Stand-Alone, No-Profile®, Integrated Interbody fusion devices was granted the first cervical multilevel indication for a Stand-Alone interbody device by the...

07:00
BLA for MCNA submitted electronically to the US FDA on June 29th, 2015 Manufacturing facility upgrades completed and pre-launch production planning initiated·         FDA waives US$2.3 million application fee for Telesta MONTREAL, June 30, 2015...


29 june 2015

08:00
MOUNTAIN VIEW, Calif., June 29, 2015 /PRNewswire/ -- The automotive industry has long been introducing new and innovative features to cars on the basis of consumer trends, preferences, safety bulletins and market positioning. The industry is now on...

08:00
- OEMs draw synergy from the healthcare and allied industries to achieve zero accidents and fatalities, finds Frost & Sullivan MOUNTAIN VIEW, California, June 29, 2015 /PRNewswire/ -- The automotive industry has long been introducing new and...

01:32
DAVAO CITY, Philippines, June 29, 2015 /PRNewswire/ -- Stockton-Agrimor Philippines, Inc. a member of the Stockton Group (STK), announced today that the Philippine's Bureau of Agriculture and Fisheries Standards has approved the full registration of...


25 june 2015

10:00
QUEBEC CITY, June 25, 2015 /CNW Telbec/ - Opsens Inc. ("Opsens" or the "Company") (TSXV: OPS) (OTCQX: OPSSF) announces that in light of the positive feedback on the performance of its products developed to measure Fractional Flow Reserve ("FFR"), the...

07:00
Syneron Candela Treatment Boosts Growth of Elastin, Collagen And Hyaluronic Acid For Younger Skin Naturally IRVINE, Calif., June 25, 2015 /CNW/ -- Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device...

07:00
CAMBRIDGE, Mass. and DEERFIELD, Ill., June 25, 2015 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) and Baxalta Incorporated, a wholly-owned subsidiary of Baxter International Inc (NYSE: BAX), today jointly announced that the New Drug...

03:00
TOKYO, June 25, 2015 /PRNewswire/ -- Press release not intended for US and UK media EU approval paves the way for LIXIANA® (edoxaban) to be made available across all European member states   Marketing authorisation is based on data from the...


24 june 2015

16:12
WASHINGTON, June 24, 2015 /PRNewswire-USNewswire/ -- Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to...

16:01
CENTENNIAL, Colo., June 24, 2015 /PRNewswire/ -- Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced today that the U.S. Food and Drug Administration (FDA) has approved the Cochleartm Nucleus® 6 Sound Processor...

13:24
KANATA, Ontario, June 24, 2015 /PRNewswire/ -- BRAEBON Medical Corporation announces today that the DentiTrac® oral appliance compliance system has passed a substantial regulatory hurdle and is now FDA cleared in the USA for use with the SomnoDent...

12:08
ROCKVILLE, Md., June 24, 2015 /PRNewswire/ --  TissueGene, Inc. today reported that the U.S. Food and Drug Administration (FDA) accepted the proposed brand name Invossa for TissueGene-C, the Company's proprietary product in development for treatment...

07:30
MISSISSAUGA, ON, June 24, 2015 /CNW/ - Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today provided an update on its international licensing initiatives for Pennsaid 2%....


23 june 2015

12:15
MINNETONKA, Minn., June 23, 2015 /PRNewswire/ -- MedNet Solutions, an innovative SaaS-based eClinical technology company that supports the entire spectrum of clinical research, is pleased to announce that iMedNettm, the company's intuitive, flexible...

11:15
SUFFOLK COUNTY, N.Y., June 23, 2015 /PRNewswire/ -- The Suffolk County Department of Health Services Bureau of Public Health Protection has contracted Decade Software Company, LLC's environmental health software EnvisionConnect, the company announced...

09:15
LAVAL, Quebec and TARRYTOWN, N.Y., June 23, 2015 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that Valeant submitted a New Drug Application to...


22 june 2015

15:00
TORONTO, June 22, 2015 /PRNewswire/ --   -- One-year outcomes from the GARFIELD-AF Registry show poor VKA control and high risk scores increased mortality and strokes in newly diagnosed atrial fibrillation (AF) patients --  Real-life data from...

08:20
PARSIPPANY, N.J. and MUMBAI, India, June 22, 2015 /PRNewswire/ -- Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 5mg/ 5ml of Oxycodone HCl...

08:04
WOODCLIFF LAKE, N.J., June 22, 2015 /PRNewswire/ -- Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved FYCOMPA® (perampanel) CIII for adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC)...

07:00
NESS ZIONA, Israel, June 22, 2015 /PRNewswire/ -- Vaxil Bio, (TASE: VAXL) a company specializing in the development of immunotherapy-based drugs, reports today that its lead product, ImMucin, has been granted an "orphan drug" designation by the US...


18 june 2015

08:00
TOKYO, June 18, 2015 /PRNewswire/ -- Daiichi Sankyo announces the initiation of Hokusai-VTE Cancer, a multinational study investigating edoxaban in venous thromboembolism (VTE) associated with cancer  Daiichi Sankyo Company, Limited (hereafter,...


17 june 2015

19:07
IRVINE, Calif., June 17, 2015 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced U.S. Food and Drug Administration (FDA) approval of its most...

08:30
NES ZIONA, Israel, June 17, 2015 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (TASE: BVXV, Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today...

06:42
NEW YORK, June 17, 2015 /PRNewswire/ -- Centinel Spinetm, Inc., (Centinel Spine) the pioneer of Stand-Alone, No-Profile®, Integrated Interbodytm fusion devices receive FDA clearance for its STALIF MIDLINE®, MIDLINE IItm, MIDLINE II-Titm (Ti-ACTIVEtm)...

03:00
LYON, France, June 17, 2015 /PRNewswire/ -- The European Commission grants marketing authorization for GARDASIL 9, the only 9-valent HPV vaccine  Sanofi Pasteur MSD announced today that the European Commission has granted marketing authorization...


16 june 2015

08:30
WESTMINSTER, Colo., June 16, 2015 /PRNewswire/ -- Cerapedics, a privately-held orthobiologics company, announced today that the U.S. Food and Drug Administration has informed the company that an advisory committee panel meeting will not be required...

08:15
JERUSALEM, June 16, 2015 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the Russian Federal Service for Intellectual Property has granted the...

08:00
HAYWARD, Calif., June 16, 2015 /PRNewswire/ -- Impax Specialty Pharma, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today that the U.S. Food and Drug Administration (FDA) has approved ZOMIG Nasal Spray for use in pediatric...

02:00
BUDAPEST, Hungary and DUBLIN, June 16, 2015 /PRNewswire/ -- Gedeon Richter Plc and Allergan Plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) notified the companies that it will require a three-month extension to...


15 june 2015

12:09
NEWTON, Mass. and JERUSALEM, June 15, 2015 /PRNewswire-USNewswire/ -- Chiasma, Inc., a U.S. privately held biopharma company, today announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)...

11:38
QUEBEC CITY, June 15, 2015 /CNW Telbec/ - Opsens Inc. (TSXV:OPS) (OTCQX:OPSSF) ("Opsens" or the "Company") today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the OptoWire and OptoMonitor, its products developed to...

11:09
ROME, June 15, 2015 /PRNewswire/ -- The FDA authorized the marketing of the Scrambler Therapy® Technology MC-5A device. This medical device has been developed in Italy for the treatment of chronic neuropathic and oncologic pain resistant to opiates...

09:00
NES ZIONA, Israel, June 15, 2015 /PRNewswire/ --BiondVax Pharmaceuticals Ltd. (TASE: BVXV, Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today...

08:03
IRVINE, Calif., June 15, 2015 /PRNewswire/ -- Breathe Technologies, Inc., a developer and manufacturer of medical technologies for patients with respiratory insufficiency and neuromuscular diseases, announced today that the U.S. Food and Drug...

08:00
RAMAT-GAN, Israel, June 15, 2015 /PRNewswire/ -- Nutrinia, developing therapies to treat rare gastrointestinal disorders, announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for the company's...

07:00
TUCSON, Ariz., June 15, 2015 /PRNewswire/ -- Ventana Medical Systems, Inc.  (Ventana), a member of the Roche Group, today announced approval of the VENTANA ALK (D5F3) CDx Assay by the US Food and Drug Administration (FDA) as a companion diagnostic to...


12 june 2015

12:15
AACHEN, Germany, SANTIAGO DE CHILE, Chile and BOSTON, June 12, 2015 /PRNewswire/ --   Partnership program with Proteus S.A. (Chile) and Boston Children's Hospital (USA)  Grünenthal's Innovative Medicines Unit driving the program in a new approach...


11 june 2015

18:31
EAST HANOVER, N.J., June 11, 2015 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) has approved Promacta® (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia...

02:00
BATH, England, June 11, 2015 /PRNewswire/ -- Atlas Genetics Ltd ("Atlas" or the "Company"), the ultra-rapid 'test and treat' molecular diagnostics company, today announces a collaboration with St George's, University of London to develop and...


10 june 2015

10:30
BALA CYNWYD, Pa., June 10, 2015 /PRNewswire/ -- Sleep Specialists, LLC, a medical device company specializing in sleep therapy, announced today that their FDA cleared Zzoma Positional Device was used in a clinical trial examining the cost...

02:00
BERGEN, Norway, June 10, 2015 /PRNewswire/ -- BerGenBio AS ("BerGenBio" or the "Company"), an oncology biopharmaceutical company, today announces that its multi-centre open label Phase 1b trial (BGBC004) of BGB324, a selective inhibitor of Axl, in...

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