Le Lézard

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

28 septembre 2016

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...

07:05
CUPERTINO, Calif., Sept. 26, 2016 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that its licensee, Pain Therapeutics (Nasdaq: PTIE) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Pain...

07:00
SINGAPORE, Sept. 26, 2016 /PRNewswire/ -- Vela Diagnostics announced today that the Sentosa® SA ZIKV RT-PCR Test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. The real-time PCR test by Vela Diagnostics...

02:30
ROCKVILLE, Maryland, 26 septembre 2016 /PRNewswire/ -- Sanaria Inc. a annoncé aujourd'hui qu'elle avait obtenu la désignation dite Fast Track de la U.S. Food and Drug Administration (FDA) pour son vaccin préventif contre le paludisme, Sanaria® PfSPZ....

01:00
TARRYTOWN, N.Y. and PARIS, Sept. 26, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application...


23 septembre 2016

18:04
THOUSAND OAKS, Calif., Sept. 23, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITAtm (adalimumab-atto) across all eligible indications of the reference product, Humira®...

16:47
SILVER SPRING, Md., Sept. 23, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Amjevita is approved for the...

16:30
DUBLIN, Sept. 23, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced the company has received approval from the U.S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA® Cohesive breast implants, offering women undergoing...

13:11
EAST HANOVER, N.J., Sept. 23, 2016 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) has granted three simultaneous approvals for the expanded use of Ilaris® (canakinumab) to treat three rare and distinct types...


22 septembre 2016

08:00
SAN DIEGO, September 22, 2016 /PRNewswire/ -- Regen BioPharma Inc. (OTCQB: RGBP), (OTCQB: RGBPP) has submitted additional data and other responses to the United States Food and Drug Administration (FDA) supporting its application requesting Orphan...


21 septembre 2016

08:00
RARITAN, N.J., Sept. 21, 2016 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. (Janssen) announced today the U.S. Food and Drug Administration (FDA) has approved INVOKAMET® XR?a once-daily, fixed-dose combination therapy of canagliflozin and metformin...


20 septembre 2016

08:00
NEWTOWN, Pa., Sept. 20, 2016 /PRNewswire/ -- KVK Tech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Lomairatm (phentermine hydrochloride USP) 8 mg tablets CIV, a low-cost, low-dose prescription medicine used for...

07:30
RAMAT GAN, Israel, September 20, 2016 /PRNewswire/ -- GI View Ltd., developer of advanced GI screening systems, announced today that it has received FDA 510(k) clearance for the new Aer-O-Scope® Colonoscope System, a disposable, self-propelled,...

06:56
PHILADELPHIA, Sept. 20, 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 Buprenorphine and Naloxone...


19 septembre 2016

16:30
WARRINGTON, Pa., Sept. 19, 2016 /PRNewswire/ -- Windtree Therapeutics, Inc. (Nasdaq: WINT), a biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, today announced that the U.S. Food and Drug...

12:19
CHICAGO, Sept. 19, 2016 /PRNewswire-USNewswire/ -- The Muscular Dystrophy Association today celebrated news of the U.S. Food and Drug Administration's decision to grant accelerated approval for eteplirsen, the first disease-modifying drug to treat...

11:26
SINGAPORE, Sept. 19, 2016 /PRNewswire/ -- QT Vascular Ltd. (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the...

10:17
SILVER SPRING, Md., Sept. 19, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is...

09:30
ZUG, Switzerland and NEW YORK, Sept. 19, 2016 /PRNewswire/ -- SELLAStm Life Sciences Group (SELLAS), a development-stage biopharmaceutical company focused on developing innovative products to treat cancer, today announced that the U.S. Food And Drug...

08:00
WHIPPANY, N.J., Sept. 19, 2016 /PRNewswire/ -- Bayer announced today that the U.S. Food and Drug Administration (FDA) approved Kyleenatm (levonorgestrel-releasing intrauterine system) 19.5 mg, a progestin-containing intrauterine system (IUS), for the...

06:45
CINCINNATI, Sept. 16, 2016 /PRNewswire/ -- No other preventable hospital complication occurs as frequently as pressure ulcers. In fact, patients who experience pressure ulcers are more likely to die during their hospital stay and are more likely...

03:00
TAIPEI, Taiwan, Sept. 19, 2016 /PRNewswire/ --  Medeon Biodesign, Inc., a Taiwan medical device company,  announces today that the company has received U.S. Food and Drug Administration 510(k) clearance for AbCloseTM, a single use, disposable...


16 septembre 2016

11:22
SILVER SPRING, Md., Sept. 16, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today permitted marketing of a device that uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure,...


15 septembre 2016

09:33
-Aralez Sales Force Will Be Expanded by 85 to 110 Sales Representatives by Launch- -YOSPRALA U.S. Commercial Launch Planned for First Week of October- -Company to Host Conference Call Today at 11:00 a.m. ET- MISSISSAUGA, Ontario, Sept. 15, 2016...

08:15
PALO ALTO, Calif., Sept. 15, 2016 /PRNewswire/ -- Varian Medical Systems (NYSE: VAR) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Nexus DR, a high resolution imaging system for X-ray...

07:00
LANDING, New Jersey, Sept. 15, 2016 /PRNewswire/ -- DolCas Biotech, LLC, received self-affirmed GRAS (Generally Recognized as Safe) status for its BCM-95® turmeric extract, following a comprehensive review by a panel of qualified experts. The pure,...


14 septembre 2016

07:00
ATLANTA and CAMBRIDGE, Mass., Sept. 14, 2016 /PRNewswire/ -- Inhibikase Therapeutics, Inc., a developer of cellular Abelson tyrosine kinase inhibitors to treat infections and other diseases in the central nervous system, has received FDA clearance to...

07:00
LEXINGTON, Massachusetts, September 14, 2016 /PRNewswire/ -- Shire plc (LSE: SHP; NASDAQ: SHPG) announced that the United States Food and Drug Administration (FDA) has granted approval for CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution]...

07:00
LEXINGTON, Massachusetts, September 14, 2016 /PRNewswire/ -- Approval follows positive data from clinical studies on efficacy and tolerability, as well as infusion time and number of injection sites  Shire plc (LSE: SHP; NASDAQ: SHPG) announced...


13 septembre 2016

16:45
SILVER SPRING, Md., Sept. 13, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in...

08:50
HAMPTON, Va., Sept. 13, 2016 /PRNewswire/ -- Registrar Corp writes to remind the food industry of an important upcoming regulatory deadline.  Under the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), food facilities that...

08:00
EVANSTON, Ill., Sept. 13, 2016 /PRNewswire/ -- Aptinyx Inc., a biopharmaceutical company developing novel modulators of the N-methyl-D-aspartate (NMDA) receptor for the treatment of challenging neurologic disorders, today announced its intention to...

07:00
LANDING, New Jersey, Sept. 13, 2016 /PRNewswire/ -- DolCas Biotech, LLC, received GRAS (Generally Recognized as Safe) status for its BCM-95® turmeric extract for use in foods, dietary supplements and medical foods, following a comprehensive review by...


12 septembre 2016

09:00
CLEVELAND, Sept. 12, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration (FDA) has issued a biologics license to the Cleveland Cord Blood Center (CCBC) for CLEVECORDtm, a stem cell product (HPC, Cord Blood) derived from umbilical...

09:00
SAN DIEGO, Sept. 12, 2016 /PRNewswire/ -- Obalon Therapeutics, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of the Obalon Balloon System, a novel, nonsurgical, fully-reversible device for weight...

07:00
SYDNEY, Sept. 12, 2016 /PRNewswire/ -- Cantrixil (TRX-E-002-1) is Novogen's lead development candidate, and is being developed as an intraperitoneal therapy for patients with ovarian cancer Investigational New Drug (IND) application is the key...

04:00
GLASGOW, Scotland, September 12, 2016 /PRNewswire/ -- MGB Biopharma, a biopharmaceutical company developing a novel class of anti-infectives to address the major global problem of antibiotic resistance, announces today that the US Food and Drug...


11 septembre 2016

13:30
LOD, Israel and AAP, SAN DIEGO, Sept. 11 2016 /PRNewswire/ --Datum Dental announced that OSSIX®  VOLUMAX has received FDA 510(k) clearance, enabling the company to commercially market this new volumizing (approx. 2 mm), resorbable collagen scaffold...


9 septembre 2016

07:00
RIDGEFIELD, Conn., Sept. 9, 2016 /PRNewswire/ -- Boehringer Ingelheim today announced that the European Commission (EC) and U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to nintedanib for the treatment of systemic...

04:35
LONDON, September 9, 2016 /PRNewswire/ -- Dechra is pleased to announce that it has received approval from the U.S. Food and Drug Administration (FDA) for a generic antibiotic. The product is expected to be a first generic market entrant in a...


1 septembre 2016

08:00
Bolus Vial to Improve Delivery Convenience WINNIPEG, Sept. 1, 2016 /CNW/ - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a specialty pharmaceutical company, announced that it has received approval from the U.S. Food and Drug...


14 mars 2016

08:00
FLINT, Mich., March 14, 2016 /PRNewswire/ -- Diplomat Pharmacy, Inc. (NYSE: DPLO) announced today that it is now filling prescriptions for the new indication of IMBRUVICA® (ibrutinib). IMBRUVICA® was recently approved by the U.S. Food and Drug...