Le Lézard

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

14 octobre 2016

09:49
BARRANQUILLA, Colombia, October 14, 2016 /PRNewswire/ -- New Colombia Resources, Inc.(OTC: NEWC) (the "Company"), a U.S. listed Colombian resource company with premium metallurgical coal and medical marijuana assets, is pleased to announce they will...


13 octobre 2016

11:57
HACKENSACK, N.J., Oct. 13, 2016 /PRNewswire-USNewswire/ -- Parent Project Muscular Dystrophy (PPMD), a nonprofit organization leading the fight to end Duchenne muscular dystrophy (Duchenne), has awarded a $239,000 grant to Dr. Terence Partridge,...


12 octobre 2016

21:00
NORTH BRUNSWICK, N.J. and TOKYO, Oct. 12, 2016 /PRNewswire/ -- Chromocell Corporation and Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the development program of the drug...

07:14
CAMBRIDGE, Massachusetts, October 12, 2016 /PRNewswire/ -- FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research.  Misconduct in clinical...


11 octobre 2016

13:15
MERIDEN, Conn., Oct. 11, 2016 /PRNewswire/ -- Protein Sciences Corporation announced today that the FDA has approved its quadrivalent formulation of Flublok® influenza vaccine.  Flublok Quadrivalent protects against 4 strains of influenza, 3 of the...

08:01
DUBLIN, Oct. 11, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company's supplemental New Drug Application (sNDA) for...

06:55
SAN DIEGO, Oct. 11, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for INGREZZATM (valbenazine) for the...

04:08
JERUSALEM, October 11, 2016 /PRNewswire/ -- Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough...


10 octobre 2016

16:05
MOUNTAIN VIEW, Calif. and BARCELONA, Spain, Oct. 10, 2016 /PRNewswire/ -- Alexza Pharmaceuticals, Inc., a wholly-owned subsidiary of Ferrer Therapeutics, Inc., today announced that its supplemental New Drug Application (sNDA) seeking certain changes...

14:40
FARGO, N.D., Oct. 10, 2016 /PRNewswire/ -- Vance Thompson Vision, a leader in ophthalmology and refractive surgery in South Dakota, North Dakota, Minnesota and Iowa is thrilled to be one of the country's first to provide Avedro's Crosslinking System...

06:00
ADELAIDE, Australia, Oct.10, 2016 /PRNewswire/ -- Clever Culture Systems AG (CCS), the Swiss based joint venture between Australian medical technology company LBT  Innovations Limited (ASX:  LBT) and Hettich AG (Switzerland) has received clearance of...


7 octobre 2016

11:00
SIOUX FALLS, S.D., Oct. 7, 2016 /PRNewswire/ -- Vance Thompson Vision, a leader in ophthalmology and refractive surgery in South Dakota, North Dakota, Minnesota and Iowa, is thrilled to be one of the country's first to provide Avedro's Crosslinking...


6 octobre 2016

21:25
COLORADO SPRINGS, Colo., Oct. 6, 2016 /PRNewswire/ -- Adapta Medical, Inc. has received FDA market release for the PerfIC Cath® intermittent touchless urinary catheter. The sterile catheter system was designed by J. Glen House, MD, a C7 quadriplegic...

08:00
MORRISTOWN, N.J., Oct. 6, 2016 /PRNewswire/ -- Orexo US announced today that the U.S. Food and Drug Administration (FDA) has approved ZUBSOLV® (buprenorphine/naloxone CIII sublingual tablet) 0.7mg/0.18mg for the treatment of patients with opioid...

08:00
KING OF PRUSSIA, Pa., Oct. 6, 2016 /PRNewswire/ -- Trice Medical announced today that it received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for mi-eye 2, a disposable needle with a fully integrated camera that enables...


5 octobre 2016

18:07
LEXINGTON, Massachusetts, October 5, 2016 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Patent & Trademark Office's Patent Trial and Appeal Board (PTAB) has issued their decision upholding the validity of U.S....

09:30
CHRISTCHURCH, New Zealand and BRASILIA, Brazil, October 5, 2016 /PRNewswire/ -- ARANZ Medical, a specialist in 3D scanning and informatics solutions for the healthcare sector, has been named the Private Sector Excellence Award winner at the World...

09:00
HINSDALE, Ill., Oct. 5, 2016 /PRNewswire/ -- Alix J. Charles, M.D., FAAD, a Hinsdale-based, board-certified Dermatologist of DuPage Medical Group (DMG) Aesthetics is pleased to be the first physician in the Chicago-area to offer UltraShape Powertm, a...

03:30
CHRISTCHURCH, New Zealand and BRASILIA, Brazil, October 5, 2016 /PRNewswire/ -- ARANZ Medical, a specialist in 3D scanning and informatics solutions for the healthcare sector, has been named the Private Sector Excellence Award winner at the World...

03:00
CHARLOTTE, N.C., Oct. 5, 2016 /PRNewswire/ -- SonaCare Medical, leading developer and manufacturer of High Intensity Focused Ultrasound (HIFU) Technologies, reports over 40 acquisitions of Sonablate® technology since the device received FDA clearance...


4 octobre 2016

16:01
SAN FRANCISCO, Oct. 4, 2016 /PRNewswire/ -- Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced it has received a technical section complete letter for effectiveness...

12:48
SILVER SPRING, Md., Oct. 4, 2016 /PRNewswire-USNewswire/ -- When your doctor prescribes a medication for your child, do you know what the correct dosage is or how to measure it? Are you comfortable asking your doctor questions when you receive a...

11:45
MISSION VIEJO, Calif., Oct. 4, 2016 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has proposed new guidelines for the use of the term "healthy" on food labeling and fresh avocados, which contribute naturally good fats to the diet, will...

09:00
MEDFORD, Mass., Oct. 4, 2016 /PRNewswire/ -- INVO Bioscience, Inc. (OTC: IVOB), a medical device company who was granted FDA clearance for the first Intravaginal Culture System, INVOcelltm, today announced the launch of a new corporate website at...

08:22
SALT LAKE CITY, Oct. 4, 2016 /PRNewswire/ -- Xenocor, Inc., an emerging leader in developing a new, revolutionary medical imaging platform that provides the most cost?effective high definition laparoscopy solutions, announced today that its first...


3 octobre 2016

15:46
En attendant le lancement de la version approuvée par Santé Canada, l'Arrêté d'urgence existant permet aux Canadiens de continuer de se procurer le vaporisateur nasal Narcan® approuvé par la FDA des É.-U. DUBLIN, Irelande, le 3 oct. 2016 /CNW/...

13:07
SILVER SPRING, Md., Oct. 3, 2016 /PRNewswire-USNewswire/ -- FDA is increasingly harnessing the power of supercomputers, the creative and collaborative culture of the scientific community, and novel approaches to technology to help achieve advances in...

11:55
Première application clinique visant à suivre l'oxygène des tissus fragilisés par une MAP SOUTH SAN FRANCISCO, Californie, 3 octobre 2016 /PRNewswire/ -- Profusa, Inc., un concepteur de biocapteurs intégrés aux tissus pour le suivi continu de la...

09:00
MAPLE GROVE, Minn., Oct. 3, 2016 /PRNewswire/ -- Nearly 12 million men in the U.S. suffer from symptoms related to benign prostatic hyperplasia (BPH), an enlargement of the prostate that can cause issues such as frequent and weak urinary streams and...

08:30
First Clinical Application Aimed At Oxygen Monitoring of Compromised Tissues in PAD SOUTH SAN FRANCISCO, California, Oct. 3, 2016 /PRNewswire/ -- Profusa, Inc., a developer of tissue-integrated biosensors for continuous...

06:57
VALENCIA, Calif., Oct. 3, 2016 /PRNewswire/ -- Valencia Technologies Corporation ("Valencia"), a privately held medical device company, announces that it has gained U.S. Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE")...


30 septembre 2016

08:00
NORTH CHICAGO, Ill., Sept. 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational,...


29 septembre 2016

01:00
PLEASANTON, Calif., Sept. 29, 2016 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX, RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension of the cobas® EGFR Mutation Test v2 for use with plasma samples as a...


28 septembre 2016

21:23
JACKSONVILLE, Fla., Sept. 28, 2016 /PRNewswire/ -- Next Sciencetm, LLC is excited to announce the approval of Next Science Irrigation Solution by the FDA for the irrigation and debridement of wounds. Next Science Irrigation Solution is an exciting...

15:35
LAS VEGAS, Sept. 28, 2016 /PRNewswire/ -- On Tuesday, September 27, Nevada Heart and Vascular Centers' Board Certified Interventional Cardiologist Rafael Valencia M.D., F.A.C.C., implanted a patient with the world's first FDA-approved dissolving...

13:45
NEW YORK, Sept. 28, 2016 /PRNewswire-USNewswire/ -- JDRF, which for a decade through its research and advocacy work has catalyzed development of artificial pancreas systems, commended the Food and Drug Administration today for being the first...

13:34
SILVER SPRING, Md., Sept. 28, 2016 /PRNewswire-USNewswire/ -- Though many people do not know it, FDA does much more to facilitate drug approval than evaluate new drug applications. We are also actively involved in drug development well before the...

13:31
SILVER SPRING, Md., Sept. 28, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Medtronic's MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose...

09:00
ROSLYN HEIGHTS, N.Y., Sept. 28, 2016 /PRNewswire/ -- The FDA has approved the newest non surgical advancement in Weight Loss procedures called AspireAssist.  New York Bariatric Group based in Roslyn Heights, NY is the first practice since FDA...

09:00
ABBOTT PARK, Ill., Sept. 28, 2016 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's FreeStyle Libre Pro system, a revolutionary continuous glucose monitoring (CGM) system...

08:43
PETACH TIKVA, Israel, September 28, 2016 /PRNewswire/ -- Emerald Medical Applications Corp. (OTCQB: MRLA) ("Emerald" or the "Company"), the Israeli-based company engaged in the development and sale of DermaComparetm, its proprietary artificial...

03:00
LYON, France, September 28, 2016 /PRNewswire/ -- Zostavax® shingles vaccine remains as part of the successful UK national immunisation programme for the next two years.  Sanofi Pasteur MSD today announced that the Department of Health (DH) has...


27 septembre 2016

10:35
TEL AVIV, Israel, September 27, 2016 /PRNewswire/ -- Kitov Pharmaceuticals Holdings Ltd. (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late stage drug development, announced today that its lead drug candidate KIT-302 has...

08:30
RAANANA, Israel, Sept. 27, 2016 /PRNewswire/ -- XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing its lead product for the treatment of lupus, today reported...

07:59
ATLANTA, Sept. 27, 2016 /PRNewswire-USNewswire/ -- The Association for Precision Pharmacy Services (APRXS) is joining with other medical watchdog groups to encourage the FDA to adopt regulations that will hold physicians' offices to the same levels...


26 septembre 2016

16:00
THOUSAND OAKS, Calif. and BRUSSELS, Sept. 26, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA)...

11:55
INDIANAPOLIS, Sept. 26, 2016 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a fully automated assay for the detection of antibodies to...

09:07
HORSHAM, Pa., Sept. 26, 2016 /PRNewswire/ -- Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved STELARA® (ustekinumab) for the treatment of moderately to severely active Crohn's disease in adults (18...

09:00
PRINCETON, New Jersey and OR AKIVA, Israel, September 26, 2016 /PRNewswire/ -- Regentis Biomaterials, a developer of hydrogels for tissue regeneration, announced it has received U.S. Food and Drug Administration (FDA) Investigational Device...

07:30
RARITAN, N.J., Sept. 26, 2016 /PRNewswire/ -- Janssen Research & Development, LLC announced today that a supplemental New Drug Application (sNDA) for ibrutinib (IMBRUVICA®) has been submitted to the U.S. Food and Drug Administration (FDA) for the...