Le Lézard

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

7 décembre 2016

07:00
MISGAV, Israel and TUTTLINGEN, Germany, Dec. 7, 2016 /PRNewswire/ -- B. Braun Melsungen AG ("B. Braun"), The Trendlines Group Ltd. (SGX: 42T, OTCQX: TRNLY) ("Trendlines") and Gordian Surgical Ltd. ("Gordian") jointly announced B. Braun's lead...


6 décembre 2016

10:17
BOSTON, Dec. 6, 2016 /PRNewswire/ -- The Amyloidosis Research Consortium (ARC) today announced the submission of a draft guidance for industry on developing drugs for AL amyloidosis to the Food and Drug Administration (FDA), to improve the design of...

10:00
La société annonce l'autorisation de la FDA et le marquage CE du système de contrôle glycémique mobile One Drop | Chrome, et le lancement officiel de son service d'abonnement mensuel, One Drop | Premium, qui peut être commandé dès maintenant aux...

10:00
Company announces FDA clearance and CE mark approval of mobile blood glucose monitoring system One Drop | Chrome, and the official launch of its monthly subscription service, One Drop | Premium, available for orders in the US, UK and EU immediately....


5 décembre 2016

08:00
RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 5, 2016 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved a new indication for Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes...

07:00
ROCKVILLE, Md., Dec. 5, 2016 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announced today that China's Food and Drug...


2 décembre 2016

13:08
SILVER SPRING, Md., Dec. 2, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus...


1 décembre 2016

16:18
NEW YORK, Dec. 1, 2016 /PRNewswire/ -- Nanowear, an early stage developer of cloth-based diagnostic monitoring nanosensor technology, today announced that it has received FDA Class II 510(k) clearance for its first product, SimplECGtm, a remote...

13:50
WAYNE, Pa., Dec. 1, 2016 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions,...

11:23
LUGANO, Suisse, December 1, 2016 /PRNewswire/ -- Helsinn Integrative Care, unité commerciale d'Helsinn spécialisée dans les produits non pharmaceutiques de soins de support en oncologie fondés sur des données factuelles, annonce aujourd'hui avoir...

07:05
HOLLISTON, Mass., Dec. 1, 2016 /PRNewswire/ -- Biostage, Inc. (Nasdaq: BSTG), ("Biostage" or the "Company"), a biotechnology company developing bioengineered organ implants to treat cancers and other life-threatening conditions of the esophagus,...

03:00
LUGANO, Switzerland, December 1, 2016 /PRNewswire/ -- Helsinn Integrative Care, Helsinn's business unit focused on evidence-based, non-pharmaceutical cancer supportive care products, today announces that Xonrid® Gel, a topical gel for...


30 novembre 2016

14:00
 - Orphan Drug Designation program provides orphan status to medications intended for the safe and effective treatment, diagnosis or prevention of rare diseases[1] - Risankizumab is an investigational treatment being evaluated in immunological...

09:25
BUENA, N.J., Nov. 30, 2016 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S....

08:30
SINGAPORE, Nov. 30, 2016 /PRNewswire/ -- CellResearch Corporation Pte Ltd ("CellResearch"), a Singapore-based company that specializes in stem cell technology, through its wholly owned subsidiary, CordLabs Pte Ltd ("CordLabs"), has entered into an...


29 novembre 2016

14:32
SAN JOSE, Calif., Nov. 29, 2016 /PRNewswire/ -- Rodo Medical, Inc., an innovative dental device company, announces FDA clearance of the Rodo Abutment System, featuring the shape-memory Smileloc® retentive sleeve. The Rodo Abutment System radically...

08:21
DARMSTADT, Germany and NEW YORK, November 29, 2016 /PRNewswire/ -- Not intended for UK-based media If approved by the FDA, avelumab, an investigational immunotherapy, could be the first treatment indicated for patients with metastatic Merkel cell...

08:00
GAITHERSBURG, Md., Nov. 29, 2016 /PRNewswire/ -- Vtesse, Inc., a company committed to developing medicines to benefit patients with ultra rare, life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Rare...


28 novembre 2016

15:45
BOCA RATON, Fla., Nov. 28, 2016 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has launched its ANDA for Armodafinil tablets (CIV) in 50mg, 150mg and 250mg strengths on November 28, 2016, after having received final...

10:00
LOS ANGELES, Nov. 28, 2016 /PRNewswire/ -- Global Health Solutions has announced 510k FDA approval of PolyPlex Wound Dressing, a first of its kind, petrolatum based topical gel indicated for acute and chronic wound management. PolyPlex Wound Dressing...

09:00
SEOUL, Korea, Nov. 28, 2016 /PRNewswire/ -- Nature Cell Co., Ltd. (Nature Cell) (CEO, Dr. Jeongchan Ra), a leading biotechnology company, announces AstroStem's approval for Phase I and Phase II clinical trials for treatment of Alzheimer's disease by...

08:30
SEATTLE, Nov. 28, 2016 /PRNewswire/ -- PhaseRx, Inc. (NASDAQ: PZRX), a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children, today announced that its lead candidate, PRX-OTC, which is being...

08:08
NESS ZIONA, Israel, Nov. 28, 2016 /PRNewswire/ --BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing a vaccine against current and future seasonal and pandemic...

06:54
PHILADELPHIA, Nov. 28, 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 Metaxalone Tablets USP, 800...


25 novembre 2016

14:43
NEWPORT NEWS, Va., Nov. 25, 2016 /PRNewswire/ -- DILON Diagnostics and GE Healthcare are pleased to announce the FDA clearance of the Molecular Breast Imaging (MBI) localization accessory for breast biopsy. The Discovery NM750b and the breast biopsy...


22 novembre 2016

16:39
LOS ANGELES, Nov. 22, 2016 /PRNewswire-USNewswire/ -- Millions of glaucoma patients whose previous surgical treatment failed to reduce their eye pressure have new hope following several years of pivotal clinical trials conducted in refractory...

11:07
NORCROSS, Ga., Nov. 22, 2016 /PRNewswire/ -- Lipogems, a leading international tissue repair company, today announced the U.S. Food and Drug Administration 510(k) clearance for expanded indications and labeling of The Lipogems® System for adipose...

07:35
DUBLIN, Nov. 22, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today the U.S. Food and Drug Administration (FDA) has cleared the XEN® Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector) for use in the U.S. The...

07:00
LANDING, New Jersey, November 22, 2016 /PRNewswire/ -- A new clinical study confirms positive effects of BCM-95®, a high-potency turmeric extract in treating Major Depressive Disorder (MDD) and anxiety.      (Photo:...

07:00
NESS ZIONA, Israel, November 22, 2016 /PRNewswire/ -- The first cases of highly pathogenic H5N6 Avian Influenza ("Bird Flu") were confirmed last week in South Korea[1]. Over 62,000 birds have been culled in an effort to prevent the spread. H5N6...


21 novembre 2016

19:51
PLAINSBORO, N.J., Nov. 21, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for Xultophy® 100/3.6 (insulin degludec 100 units/mL and...

19:19
PARIS, Nov. 21, 2016 /PRNewswire-USNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved once-daily Soliquatm 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of...

16:37
HORSHAM, Pa., Nov. 21, 2016 /PRNewswire/ -- Janssen Biotech, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone,...

10:30
IDAHO FALLS, Idaho, Nov. 21, 2016 /PRNewswire/ -- International Isotopes Inc. (OTCQB: INIS) (the "Company") announces that it has submitted an abbreviated new drug application (aNDA) to the U.S. Food and Drug Administration (FDA) for its...

09:00
PORT WASHINGTON, New York, November 21, 2016 /PRNewswire/ -- Equashield, a leading provider of Closed System Transfer Devices (CSTD) for safe and simple handling of hazardous drugs, announced today that it is expanding its range of solutions and...

09:00
OXFORD, England, November 21, 2016 /PRNewswire/ -- Oxitec announced today the Board of the Florida Keys Mosquito Control District (FKMCD) voted to approve the investigational agreement for use of self-limiting Friendlytm mosquitoes in an...

08:30
PARSIPPANY, New Jersey, November 21, 2016 /PRNewswire/ -- Ascensia Diabetes Care announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CONTOUR® NEXT ONE Blood Glucose Monitoring System (BGMS), marking a key step...

08:28
PHILADELPHIA, Nov. 21, 2016 /PRNewswire/ -- GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research expanding the indication for FluLaval® Quadrivalent...

06:30
MISSISSAUGA, ON, Nov. 21, 2016 /CNW/ - GlaxoSmithKline Inc. (GSK) has submitted a New Drug Submission (NDS) for its candidate shingles vaccine, seeking approval for the prevention of herpes zoster (shingles) and its complications in Canadians aged 50...

06:30
MISSISSAUGA, ON, le 21 nov. 2016 /CNW/ - GlaxoSmithKline Inc. (GSK) a déposé une présentation de drogue nouvelle pour son vaccin expérimental contre le zona afin de le faire approuver pour la prévention du zona et de ses complications chez les...


17 novembre 2016

09:34
SILVER SPRING, Md., Nov. 17, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and...

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...