Le Lézard

Communiqués de presse par sujet : Approbation de la FDA (Food and Drug Administration)

17 novembre 2016

08:00
HORSHAM, Pa., Nov. 17, 2016 /PRNewswire/ -- Janssen Biotech, Inc. (Janssen) announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of guselkumab for the treatment of...


16 novembre 2016

08:06
SAN DIEGO, Nov. 16, 2016 /PRNewswire/ -- Amplyx Pharmaceuticals, a company developing novel antifungal agents for life-threatening fungal infections, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Product...

07:00
ADULTS 65+ SHOULD CONSIDER THIS VACCINE TO HELP PREVENT AGAINST PNEUMOCOCCAL PNEUMONIA KIRKLAND, QC, Nov. 16, 2016 /CNW/ - The National Advisory Committee on Immunization (NACI) concludes that there is good evidence to recommend, on an individual...

07:00
LES ADULTES DE 65 ANS ET PLUS DEVRAIENT ENVISAGER CE VACCIN POUR PRÉVENIR LA PNEUMONIE PNEUMOCOCCIQUE KIRKLAND, QC, le 16 nov. 2016 /CNW/ - Le Comité consultatif national de l'immunisation (CCNI) conclut qu'il existe des données probantes...

06:00
SAN DIEGO, Nov. 16, 2016 /PRNewswire/ -- Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, is pleased to announce the US Food and Drug Administration (FDA) clearance of QUANTA Lite...


14 novembre 2016

08:00
CAMBRIDGE, Mass., Nov. 14, 2016 /PRNewswire/ -- Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stemness pathways, announced that its lead investigational compound, napabucasin, has received...

08:00
LEIDEN, The Netherlands, November 14, 2016 /PRNewswire/ -- Pharming Group N.V. (the "Company") (EURONEXT: PHARM) today announced that the results of its "Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human C1 Inhibitor for...

07:00
REDWOOD CITY, Calif., Nov. 14, 2016 /PRNewswire/ -- ARMO BioSciences, Inc., a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted the Company's lead investigational immuno-oncology drug AM0010...

06:56
PHILADELPHIA, Nov. 14, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Memantine Hydrochloride...


10 novembre 2016

14:09
WASHINGTON, Nov. 10, 2016 /PRNewswire-USNewswire/ -- Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids The United States is tied for last in the world in the size of warning labels required on cigarette packs, according to a...


8 novembre 2016

11:13
Cannabis Oil Capsules approved for sale by Health Canada MARKHAM, ON, Nov. 8, 2016 /CNW/ - MedReleaf, Canada's leading medical cannabis licensed producer, today announced it has become the first licensed producer (LP) to bring cannabis capsules to...

09:00
IRVINE, Calif., Nov. 8, 2016 /PRNewswire/ -- Syneron Medical Ltd. (NASDAQ: ELOS), a leading global aesthetic device company, announced today that it has achieved two major milestones to further strengthen Profound's position in the marketplace....

08:30
LOGAN, Utah, Nov. 8, 2016 /PRNewswire/ -- KATOR, a start-up medical device company focused on advanced tissue-to-bone reattachment systems, announces that it has received its second FDA 510(k) clearance for its innovative KATOR Suture Anchor...

07:35
CHESTERFIELD, United Kingdom, Nov. 8, 2016 /PRNewswire/ -- Mallinckrodt Pharmaceuticals (NYSE: MNK), a leading global specialty pharmaceutical company, announced today the U.S. Food and Drug Administration (FDA) has approved a Prior Approval...

04:00
NESS ZIONA, Israel and WALTHAM, Massachusetts, November 8, 2016 /PRNewswire/ -- Eloxx Pharmaceuticals, a biotechnology company focused on discovery, development and commercialization of compounds for the treatment of genetic diseases caused by...

04:00
NESS ZIONA, Israel et WALTHAM, Massachusetts, November 8, 2016 /PRNewswire/ -- Eloxx Pharmaceuticals, une société de biotechnologie axée sur la découverte, le développement et la commercialisation de composés pour le traitement des maladies...


7 novembre 2016

10:00
TUCSON, Arizona, Nov. 7, 2016  /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX:RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved  the VENTANA ALK (D5F3) CDx Assay1 for use on the VENTANA BenchMark ULTRA...

06:00
MADISON, Wis., Nov. 7, 2016 /PRNewswire/ -- Propeller Health, the leading digital solution for respiratory medicine, today announced U.S. Food and Drug Administration 510(k) clearance to market its Propeller platform for use with GSK's Ellipta®...


4 novembre 2016

17:26
THOUSAND OAKS, Calif., Nov. 4, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded use of ENBREL® (etanercept),...

11:57
MUMBAI, November 4, 2016 /PRNewswire/ -- Pharma Major Lupin Limited (Lupin) announced today that it has received notification that the inspection carried out by the US FDA in March 2016 at its Goa facility is now closed and the agency has issued an...


3 novembre 2016

08:30
SAN DIEGO, Nov. 3, 2016 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has accepted Genentech's Biologics License Application for a subcutaneous formulation of rituximab in...


2 novembre 2016

11:22
SAN FRANCISCO, Nov. 2, 2016 /PRNewswire/ --  Arterys, a pioneer in cloud-based medical imaging software, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Arterys Software. This clearance allows...

09:00
NEW YORK, November 2, 2016 /PRNewswire/ -- E-QURE Corp. (OTCQB: EQUR), a Delaware corporation engaged in the commercialization of its Bio-electrical Signal Therapy device ("BST Device"), a new and novel electrotherapy for the non-invasive treatment...


1 novembre 2016

11:01
ROCKVILLE, Md., Nov. 1, 2016 /PRNewswire/ -- TissueGene, Inc. (TGI), a Maryland-based regenerative medicine company, today announced an exclusive licensing and development agreement between Mitsubishi Tanabe Pharma Corporation of Japan (4508:JP...

08:02
MODI'IN, Israel, Nov. 1, 2016 /PRNewswire/ -- Exalenz Bioscience (TASE: EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced receiving...


31 octobre 2016

09:23
TEL AVIV, Israel, October 31, 2016 /PRNewswire/ -- Therapix Biosciences, (OTCQB: THXBY) (TASE: THXBY.TA) the pharma company specializing in the development and commercialization of cannabinoid-based drugs, announced the successfully completion of...

07:30
CAMBRIDGE, Mass., Oct. 31, 2016 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for generic...

07:12
PARSIPPANY, N.J., Oct. 31, 2016 /PRNewswire/ -- Onkos Surgical, an innovative surgical oncology company founded by Patrick Treacy, Anthony Koblish and 1315 Capital has announced today it has received clearance from the U.S. Food and Drug...

06:59
FRANKLIN LAKES, N.J., Oct. 31, 2016 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) market authorization for a first-of-its-kind...


28 octobre 2016

13:46
SILVER SPRING, Md., Oct. 28, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to be...

09:47
DUBLIN, Oct. 28, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for RESTASIS MULTIDOSEtm (Cyclosporine Ophthalmic Emulsion) 0.05%, a preservative-free,...

09:14
RARITAN, N.J., Oct. 28, 2016 /PRNewswire/ -- Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, today announced that the U.S. Food and Drug Administration has cleared its VITROS® Automation Solutions for use with Ortho's...


27 octobre 2016

12:05
WASHINGTON, Oct. 27, 2016 /PRNewswire-USNewswire/ -- Last week, regenerative medicine investigators at Cedars-Sinai Medical Center in Los Angeles, Calif. received approval from the U.S. Food and Drug Administration (FDA) to test a combination stem...

10:00
First FDA-approved test to support patient treatment decisions for TECENTRIQ (atezolizumab) in non-small cell lung cancer TUCSON, Arizona, Oct. 27, 2016 /PRNewswire/ -- Roche (SIX: RO, ROG? OTCQX:RHHBY) today announced approval of the...

07:00
NEW YORK, Oct. 27, 2016 /PRNewswire/ -- Immune Pharmaceuticals (NASDAQ:IMNP) (Immune) announced today that it has received guidance from the United States Food and Drug Administration (FDA) on a phase III study for Ceplene in combination with low...


26 octobre 2016

13:25
HERTFORDSHIRE, England and PITTSBURGH, Oct. 26, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launches of the first generic versions of Daiichi Sankyo's Benicar® and Benicar HCT®, Olmesartan Medoxomil Tablets, 5 mg, 20...


25 octobre 2016

08:30
SOMERVILLE, N.J., Oct. 25, 2016 /PRNewswire-USNewswire/ -- Ethicon* announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for EVARREST® Fibrin Sealant Patch, which leverages biologics to rapidly and...


24 octobre 2016

08:00
SAN DIEGO, Oct. 24, 2016 /PRNewswire/ -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced that its product...

08:00
BEIJING, Oct. 24, 2016 /PRNewswire/ -- Yisheng Biopharma Co., Ltd. ("Yisheng Biopharma"), a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immuno-therapeutic products and vaccines, today...

06:00
WOOBURN GREEN, England, October 24, 2016 /PRNewswire/ -- Provides Pan-European Availability of Widely-used and Much Needed Oral Liquid Version Tlobazam Tablets  Martindale Pharma, the UK-based international specialty pharmaceutical company, today...


22 octobre 2016

09:04
RARITAN, N.J., Oct. 22, 2016 /PRNewswire/ -- Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that ORTHO VISION® Max, a fully automated blood analyzer for high-volume transfusion medicine laboratories, received...


21 octobre 2016

15:04
PLEASANTON, Calif., Oct. 21, 2016 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas® MPX test for use on the cobas® 6800 and 8800 Systems....

11:55
TOKYO and NEW YORK, Oct. 21, 2016 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503) and Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S....


20 octobre 2016

15:40
MODESTO, Calif., Oct. 20, 2016 /PRNewswire/ -- Following up on the recent announcement from FDA about new guidance on the term healthy, and how almonds?full of naturally good fats?now meet the updated definition, there's more good nutrition news...

14:35
DUBLIN and MILFORD, Pa., Oct. 20, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, and Serenity Pharmaceuticals, LLC, announced today that the US Food and Drug Administration (FDA) Bone, Reproductive and...


19 octobre 2016

15:49
INDIANAPOLIS, Oct. 19, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has granted approval of LARTRUVOtm (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for...

14:12
SILVER SPRING, Md., Oct. 19, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today granted accelerated approval to Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS), which are...

06:57
PHILADELPHIA, Oct. 19, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) received a notice from the U.S. Food and Drug Administration (FDA) that it will seek to withdraw approval of the Company's Abbreviated New Drug Application (ANDA) for...


18 octobre 2016

12:54
STATE COLLEGE, Pa., Oct. 18, 2016 /PRNewswire/ -- Keystone Nano is pleased to announce that that it has received orphan drug status for the use of Ceramide to treat Liver Cancer from the FDA.  This very important designation provides key benefits to...

08:50
SUZHOU, China, Oct. 18, 2016 /PRNewswire/ -- CStone Pharmaceuticals announced today that, following the successful site inspection by the Jiangsu FDA for its recombinant anti PD-L1 monoclonal antibody (WBP3155), the CFDA has recently accepted the...