Le Lézard

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

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29 mars 2017

06:02
WAYNE, Pa., March 29, 2017 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, today...


28 mars 2017

13:50
TARRYTOWN, N.Y. and PARIS, March 28, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi will hold a conference call for the financial community to discuss the U.S. Food and Drug Administration approval of DUPIXENT®...

11:47
SILVER SPRING, Md., March 28, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients...

11:40
TARRYTOWN, N.Y. and PARIS, March 28, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved DUPIXENT® (dupilumab) Injection, the first and only biologic...

11:40
BRIDGEWATER, N.J. and TARRYTOWN, N.Y., March 28, 2017 /PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) Injection, the first and only biologic...

11:17
MIAMI, March 28, 2017 /PRNewswire-USNewswire/ -- Upper extremity amputees are one step closer to successfully picking up a cookie and an egg, thanks to a new advanced prosthetic system that is designed to restore sensation. The U.S. Food and Drug...

10:37
DALLAS, March 28, 2017 /PRNewswire/ -- SYNERGY MEDSALES, INC., a global leader in aesthetic device sales, has announced that it has signed an agreement with FormaTK Systems Ltd. to market and distribute their latest FDA-approved laser technologies:...


27 mars 2017

16:14
SILVER SPRING, Md., March 27, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian,...

15:47
WALTHAM, Mass., March 27, 2017 /PRNewswire/ -- TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved ZEJULAtm (niraparib), an oral, once-daily...

08:58
TEL AVIV, Israel, March 27, 2017 /PRNewswire/ -- Combined treatment of TyrNovo's NT219 with targeted cancer drugs overcame acquired resistance of colon, lung, and head-and-neck cancers in PDX models Kitov Pharmaceuticals (NASDAQ and TASE: KTOV),...

08:00
NASHUA, N.H., March 27, 2017 /PRNewswire/ -- iCAD (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that...


23 mars 2017

21:15
BOTHELL, Wash., March 23, 2017 /PRNewswire/ -- Mirabilis Medical, a Seattle-area developer of advanced medical technology for non-invasive surgery, announced today CE Mark authorization for marketing of the Mirabilis System for treatment of uterine...

17:30
ROCKLAND, Mass. and NEW YORK, March 23, 2017 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA)...

14:49
SILVER SPRING, Md., March 23, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel...

10:15
CRANBURY, N.J., March 23, 2017 /PRNewswire/ -- Cornerstone Pharmaceuticals, Inc., a clinical-stage, oncology-focused pharmaceutical company, announced a major milestone today.  Following successful End-of-Phase I (EOP1) Type B meetings with the U.S....

08:57
WINNIPEG, March 23, 2017 /CNW/ - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a leading Canadian specialty pharmaceutical company, is pleased to announce that its majority-owned subsidiary, Apicore Inc., has received final...

08:30
JERUSALEM, March 23, 2017 /PRNewswire/ -- Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that orphan drug designation has been granted by the European Medicines Agency's...

08:00
NEWARK, N.J., March 23, 2017 /PRNewswire/ -- Symbiomix today announced that the US Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for its lead investigational product candidate Solosectm...

07:00
TEL AVIV, Israel, March 23, 2017 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that it has acquired Agalimmune Ltd., a private UK-based company with...


22 mars 2017

09:00
WALTHAM, Massachusetts, March 22, 2017 /PRNewswire/ -- EarlySense, the market leader in Contact-Free Continuous Monitoring solutions, announced today that Newton-Wellesley Hospital, a nationally recognized medical center and a member of Partners...


21 mars 2017

15:17
SILVER SPRING, Md., March 21, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson's disease who are currently taking levodopa/carbidopa...

09:00
SAN DIEGO, March 21, 2017 /PRNewswire/ -- Tarrex Biopharma, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application for TX803, a novel treatment for colorectal...


20 mars 2017

13:14
HERTFORDSHIRE, England and PITTSBURGH, March 20, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S....

08:00
PHILADELPHIA, March 20, 2017 /PRNewswire/ -- Trovita Health Science, an emerging life science company specializing in medical nutrition, announces U.S. Food and Drug Administration marketing authorization of the new SAFE-T FEEDtm device for...

07:31
DUBLIN, March 20, 2017 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market JUVÉDERM VOLLUREtm XC, for...

07:00
TEL AVIV, Israel, March 20, 2017 /PRNewswire/ -- - Results to date confirm that single injection of BL-8040 mobilizes sufficient amounts of cells required for allogeneic transplantation without need for G-CSF -  - Top-line results expected by...


16 mars 2017

10:00
CAESAREA, Israel, March 16, 2017 /PRNewswire/ -- Itamar Medical Ltd. (TASE: ITMR) reports that AASM, the leading medical association of sleep medicine physicians in the United States, has published an updated version of its Clinical...

02:00
ZUG, Switzerland, March 16, 2017 /PRNewswire/ -- CINRYZE is now the first and only Hereditary angioedema treatment approved for routine prevention in paediatrics  Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the European Commission (EC)...


15 mars 2017

08:40
LOGAN, Utah, March 15, 2017 /PRNewswire/ -- First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for new...


14 mars 2017

17:29
GUILDFORD, England, March 14, 2017 /PRNewswire/ -- PRESS RELEASE - CORRECTION   Positive scientific opinion under Early Access to Medicines Scheme (EAMS) recognises burden of severe atopic dermatitis and the significant unmet need of...

13:27
VILNIUS, Lithuania, March 14, 2017 /PRNewswire/ -- Patients suffering from rare blood disorders will benefit from networks of excellence across the European Member States.   At the third conference on European Reference Networks (ERNs) yesterday in...

12:54
SILVER SPRING, Md., March 14, 2017 /PRNewswire-USNewswire/ -- Yesterday, U.S. District Judge Marcia S. Krieger for the U.S. District Court for Colorado entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC,...

04:30
GUILDFORD, England, March 14, 2017 /PRNewswire/ -- Positive scientific opinion under Early Access to Medicines Scheme (EAMS) recognises burden of severe atopic dermatitis and the significant unmet need of patients  Sanofi, and its...


13 mars 2017

15:56
EAST HANOVER, N.J., March 13, 2017 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved Kisqali® (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of...

13:00
Conavi's advanced technology platform is now available to Canadian physicians performing minimally invasive cardiovascular procedures that treat atrial fibrillation, structural heart disease and other cardiac conditions. TORONTO, March 13, 2017...

09:38
ROCKVILLE, Md., March 13, 2017 /PRNewswire/ -- At this time, most sequencing tests performed for clinical applications in the U.S. are laboratory developed tests (LDTs), according to Kalorama Information, meaning that the serviced is performed by...

09:30
NESS ZIONA, Israel, March 13, 2017 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV),  a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, reports the...

09:00
TEL AVIV, Israel, March 13, 2017 /PRNewswire/ -- Neurim Pharmaceuticals ('Neurim') announced today that it has entered into a licensing agreement with Biocodex. The agreement grants Biocodex exclusive marketing rights for Neurim's new Rx PedPRM in...


10 mars 2017

08:00
JERUSALEM, March 10, 2017 /PRNewswire/ -- Intec Pharma Ltd. (NASDAQ; TASE: NTEC), a clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology, today announced that it has entered...


9 mars 2017

09:59
MCHENRY, Ill., March 9, 2017 /PRNewswire/ -- Medela LLC has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market ENFit Low Dose Tip enteral syringes. When used as intended, the ENFit Low Dose Tip can help to deliver...

08:00
RIDGEFIELD, Conn., March 9, 2017 /PRNewswire/ -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of...

08:00
SAN DIEGO, March 9, 2017 /PRNewswire/ -- eFFECTOR Therapeutics today announced that its lead product candidate, eFT508, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of diffuse large B-cell...

07:00
Sunnybrook Health Sciences Centre with Sunnybrook Research Institute is the first Canadian Customer Site for the ExactVutm system TORONTO, March 9, 2017 /PRNewswire/ - Exact Imaging (www.exactimaging.com), the world's leader in high resolution...


8 mars 2017

09:01
TEL AVIV, Israel, March 8, 2017 /PRNewswire/ -- Definitive agreement grants Kuhnil Pharmaceutical Co. Ltd. an exclusive license to manufacture and market KIT-302 in South Korea  Transaction is Kitov's First License Agreement for KIT-302  Celecoxib...

08:42
PETAH TIKVA, Israel, March 8, 2017 /PRNewswire/ -- PolyPid Ltd., an emerging clinical-stage specialty pharmaceutical company focused primarily on the development of a post-surgical anti-infective pipeline, announced today that the Company's lead...

08:00
BUENA, N.J., March 8, 2017 /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....

08:00
DUBLIN, Ireland, March 8, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's supplemental New Drug Application...


7 mars 2017

11:00
BREA, Calif., March 7, 2017 /PRNewswire/ -- Beckman Coulter Diagnostics announces FDA clearance and U.S. commercial launch of its new DxC 700 AU chemistry analyzer. The new system brings together the advanced capabilities of two successful Beckman...

10:49
MAHWAH, N.J., March 7, 2017 /PRNewswire/ -- Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application to begin a Phase...

10:00
WATERLOO, ON, March 7, 2017 /CNW/ - Intellijoint Surgical® Inc., a privately-held Canadian medical technology company, announces FDA clearance of intellijoint HIP® Anterior, the newest application to the intellijoint HIP suite. intellijoint HIP...

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