Le Lézard

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

13 mars 2017

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...

09:00
MORRISVILLE, North Carolina, March 7, 2017 /PRNewswire/ -- Worldwide Clinical Trials (http://www.worldwide.com) and Bellerophon Therapeutics (http://www.bellerophon.com) have been selected as finalists in the 2017 Clinical Research & Excellence...

03:11
STOCKHOLM, Mar 07, 2017 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobitm) today announces that FDA has approved in-use storage at room temperature (25°C or less) for up to 45 days for all strengths of Orfadin® capsules (2 mg, 5 mg, 10 mg...


6 mars 2017

13:55
LEXINGTON, Massachusetts, March 6, 2017 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases and highly specialized conditions, will present data assessing primary immunodeficiency (PI) patient treatment...

08:00
SOUTH PLAINFIELD, N.J., March 6, 2017 /PRNewswire/-- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the filing over protest of PTC's New Drug Application (NDA) for Translarnatm...

08:00
LOS ANGELES, March 6, 2017 /PRNewswire-USNewswire/ -- The first patient in Los Angeles to receive the recently FDA-approved corneal cross-linking (CXL) procedure to help prevent blindness from keratoconus, was recently treated by experts at the...

08:00
BUENA, N.J., March 6, 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....


3 mars 2017

15:05
SILVER SPRING, Md., March 3, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as...

09:00
HOUSTON, March 3, 2017 /PRNewswire/ -- The 16th annual global food safety conference proved to be record-breaking on several dimensions. Nearly 1200 delegates from 54 countries trekked to Houston, TX to collaborate, resulting in record-breaking...

08:22
HOUSTON, March 3, 2017 /PRNewswire/ -- La 16e Conférence mondiale annuelle sur la sécurité alimentaire a démontré qu'elle pouvait battre des records à plusieurs égards. Près de 1 200 délégués originaires de 54 pays ont convergé vers Houston, au...


2 mars 2017

15:34
WASHINGTON, March 2, 2017 /PRNewswire-USNewswire/ -- Truth Initiative and the Campaign for Tobacco-Free Kids today criticized as wholly inadequate an agreement reached between the Food and Drug Administration (FDA) and Santa Fe Natural Tobacco...

08:03
NEW YORK and SYDNEY, March 2, 2017 /PRNewswire/ -- EnGeneIC Ltd., a clinical stage biopharmaceutical company focused on developing its proprietary EDVtm nanocell platform for targeted cyto-immunotherapy in cancer, announced that U.S. Food and Drug...

07:00
HOLON, Israel, March 2, 2017 /PRNewswire/ -- Compugen Ltd. (NASDAQ: CGEN), a leading therapeutic discovery company, announced today that two abstracts, the first covering data of its lead pipeline product and another on its predictive discovery...

02:41
STOCKHOLM, Mar 02, 2017 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobitm) (STO:SOBI) has received approval from the European Medicines Agency (EMA) for the grouped type II 15 K Variation for Elocta® (efmoroctocog alfa). The variation...


1 mars 2017

18:36
HØRSHOLM, Denmark, March 1, 2017 /PRNewswire/ -- ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for its house dust mite (HDM) sublingual...

17:22
SILVER SPRING, Md., March 1, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite (HDM)-induced nasal...

08:55
DUBLIN, March 1, 2017 /PRNewswire/ -- Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application referencing Eli Lilly and Company's...

08:30
RICHMOND, Calif., March 1, 2017 /PRNewswire/ -- Sangamo Therapeutics, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB-913, a...

06:20
HOUSTON, March 1, 2017 /PRNewswire/ -- L'Initiative mondiale pour la sécurité alimentaire (IMSA) a tenu aujourd'hui une conférence de presse afin de lancer la 16[e] Conférence internationale sur la sécurité alimentaire, d'annoncer la publication...


28 février 2017

19:00
SHANGHAI, Feb. 28, 2017 /PRNewswire/ -- WuXi AppTec, a leading global pharmaceutical, biotechnology and medical device open-access capability and technology platform company, today announced that its Lab Testing Division(LTD)'s Bioanalytical facility...

16:56
SILVER SPRING, Md., Feb. 28, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid...

15:56
THE WOODLANDS, Texas, Feb. 28, 2017 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that the U.S. Food and Drug Administration (FDA) has approved XERMELOtm (telotristat ethyl) 250 mg as a first and only orally...

14:50
HOUSTON, February 28, 2017 /PRNewswire/ -- The Global Food Safety Initiative (GFSI) today held a press conference to launch the 16th Global Food Safety Conference, announce the release of a new edition of GFSI's flagship Benchmarking Requirements...

09:00
TIRAT CARMEL, Israel, February 28, 2017 /PRNewswire/ -- The American College of Radiology (ACR) published updated guidelines (Feb. 19, 2017) regarding the NEMA XR-29 (MITA Smart Dose) Standard, finally setting a clear and specific set of guidelines...

08:00
MOUNTAIN VIEW, Calif., Feb. 28, 2017 /PRNewswire/ -- IRIDEX Corporation (Nasdaq: IRIX) is pleased to announce the availability of the G-Probetm Illuminate, a new, FDA-cleared probe offering combined transillumination and laser fiber for targeted...

07:00
ROCKLAND, Massachusetts and NEW YORK, February 28, 2017 /PRNewswire/ -- Second Biologics License Application accepted by the FDA for avelumab  Prognosis for urothelial carcinoma is currently poor, particularly when the disease has metastasized  ...


27 février 2017

11:30
CLEVELAND, Feb. 27, 2017 /PRNewswire/ -- Announces Fourth Quarter and Full Year 2016 Financial Highlights, including Record Revenue and $133.2 million in Backlog ViewRay, Inc. (Nasdaq: VRAY) announced today that the company received 510(k) clearance...

08:30
ROCKVILLE, Md., Feb. 27, 2017 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that its...

08:00
MONROE TOWNSHIP, N.J., Feb. 27, 2017 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the U.S. Food and Drug Administration (FDA)...

08:00
AMSTERDAM, Feb. 27, 2017 /PRNewswire/ -- Royal Philips (NYSE:PHG AEX: PHIA), a global leader in health technology, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ElastQ Imaging capability, further...

06:01
SAN DIEGO, Feb. 27, 2017 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for...

01:30
LAVAL, Quebec and SOPHIA ANTIPOLIS, France, Feb. 27, 2017 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc.'s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. (NYSE Euronext Paris: COX) today announced the...


24 février 2017

08:03
DARMSTADT, Germany, February 24, 2017 /PRNewswire/ -- Not intended for U.S. and UK based media  Ready-to-use pre-filled pen provides a convenient treatment option for patients  Simplified injection device for self-administration comes in...


23 février 2017

17:30
SILVER SPRING, Md., Feb. 23, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or...

09:00
NEW YORK, February 23, 2017 /PRNewswire/ -- Could potentially shorten study period by more than six months E-QURE Corp. (OTCQB: EQUR), a leader in medical devices for the treatment of advanced wound care, announced today that it has received...