Le Lézard

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

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...

08:00
SAN DIEGO, Feb. 23, 2017 /PRNewswire/ -- Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced the U.S. Food and Drug Administration (FDA) has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the...

07:30
EAST HANOVER, N.J., Feb. 23, 2017 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) accepted the Company's supplemental New Drug Application (sNDA) for filing, and granted Priority Review for the expanded use of...

07:00
Protocol comments and recommendations incorporated CALGARY, Feb. 23, 2017 /CNW/ - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX: RVX) today announced the receipt of the final minutes of an in-person Type B meeting with the Cardiovascular...

07:00
TEL-AVIV, Israel, February 23, 2017 /PRNewswire/ -- BioLight Life Sciences Ltd. (TASE: BOLT) ("BioLight"), an emerging global ophthalmic company focused on the discovery, development and commercialization of products and product candidates which...

00:01
MEDFORD, Mass., Feb. 23, 2017 /PRNewswire/ -- Seventh Sense Biosystems, Inc. (7SBio) announced today that a new blood collection device called TAP has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The technology represents a...


22 février 2017

08:00
SEATTLE, Feb. 22, 2017 /PRNewswire/ -- Immunexpress, Inc., a molecular diagnostic company committed to improving outcomes for suspected sepsis patients and healthcare providers, today announced it has received 510(k) clearance from the U.S. Food and...

08:00
CAESAREA, Israel, February 22, 2017 /PRNewswire/ -- LifeBond, a leader in the development of bio-surgical medical devices for tissue repair, announced today that 20 leading medical centers in the United States and Western Europe are now recruiting...

07:58
ROCKVILLE, Md., Feb. 22, 2017 /PRNewswire/ -- Kalorama Information presents five news stories related to in vitro diagnostics that represent significant developments.  Among the top news stories in IVD this month, Roche moves into the hematology...

06:59
FRANKLIN LAKES, N.J., Feb. 22, 2017 /PRNewswire/ -- Effective Feb. 13, 2017, the Food and Drug Administration (FDA) has reclassified antigen based rapid influenza virus antigen detection systems (RIDTs) intended to detect influenza virus directly...

06:54
PHILADELPHIA, Feb. 22, 2017 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it was notified by U.S. Food and Drug Administration (FDA) late yesterday afternoon that FDA suspended indefinitely the deadline for the Company to...


20 février 2017

07:30
NETANYA, Israel, February 20, 2017 /PRNewswire/ -- Intensix, developer of a real-time predictive analytics platform for early detection of patient deterioration in the ICU and high acuity departments of hospitals, announced today the positive...


17 février 2017

08:42
DUBLIN, Feb. 17, 2017 /PRNewswire/ -- Perrigo Company plc (NYSE, TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 5...


16 février 2017

08:08
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Feb. 16, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted...

08:00
RIDGEFIELD, Conn., Feb. 16, 2017 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved SPIRIVA RESPIMAT for the long-term, once-daily maintenance treatment of asthma in...

07:00
LAVAL, Quebec, Feb. 16, 2017 /CNW/ -- Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SILIQtm (brodalumab)...


15 février 2017

17:56
SILVER SPRING, Md., Feb. 15, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is administered as an injection. Siliq is intended...

10:42
LAKE OSWEGO, Ore. and BUELACH, Switzerland, Feb. 15, 2017 /PRNewswire/ -- PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System from BIOTRONIK gained FDA approval utilizing results from the BIOHELIX-I clinical study. This stent, which has...

08:00
MILAN, February 15, 2017 /PRNewswire/ --  IBSA announced today that the US Food and Drug Administration (FDA) has approved Tirosint-SOL (levothyroxine sodium oral solution), a liquid form of levothyroxine for the following two conditions:...

07:00
SUNNYVALE, Calif., Feb. 15, 2017 /PRNewswire/ -- Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Flu and Xpert Xpress Flu/RSV. Both tests deliver reference-quality...

03:00
MILAN, February 15, 2017 /PRNewswire/ -- Clinical Studies have Demonstrated that Tirosint-sol may Overcome Some of the Limitations of Levothyroxine Tablets   IBSA announced today that the US Food and Drug Administration (FDA) has approved...

02:00
MILAN, February 15, 2017 /PRNewswire/ -- Des études cliniques ont démontré que Tirosint-SOL peut vaincre certaines des limites inhérentes aux comprimés de lévothyroxine    IBSA a annoncé aujourd'hui que le Secrétariat américain aux produits...


13 février 2017

09:08
RAANANA, Israel, February 13, 2017 /PRNewswire/ -- Dr. Robert I. Fox and Professor Simon Bowman are world-renowned rheumatologists and experts in Sjogren's syndrome    XTL Biopharmaceuticals Ltd., is a clinical-stage biotech company focused on the...

09:02
PETAH TIKVA, Israel, February 13, 2017 /PRNewswire/ -- The Institute for Endocrinology and Diabetes at Schneider Children's Medical Center in Petah Tikva, Israel, along with the International Diabetes Center (IDC) received a grant of $6.94 million...


9 février 2017

17:55
CHICAGO, Feb. 9, 2017 /PRNewswire-USNewswire/ -- The Muscular Dystrophy Association today welcomed news of the U.S. Food and Drug Administration's decision to grant approval for deflazacort (brand name Emflaza), under development by Marathon...

13:54
SILVER SPRING, Md., Feb. 9, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD), a rare...

08:00
SAN DIEGO, Feb. 9, 2017 /PRNewswire/ -- Access Scientific, LLC, announced today the FDA clearance of its new 3 French, 6cm POWERWANDtm-- the first true Extended-Dwell Intravenous Catheter (EDC). The IV catheter is uniquely designed for forearm and...


8 février 2017

06:45
INDIANAPOLIS, Feb. 8, 2017 /PRNewswire/ -- The label for Eli Lilly and Company's (NYSE: LLY) once-weekly Trulicity® (dulaglutide) is now updated to include use in combination with basal insulin for adults with type 2 diabetes. The U.S. Food and Drug...


7 février 2017

18:13
THOUSAND OAKS, Calif., Feb. 7, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Parsabivtm (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adult...

10:30
ELSTREE, United Kingdom and DURHAM, N.C., Feb. 7, 2017 /PRNewswire/ -- Bio Products Laboratory Limited (BPL), a leading manufacturer of plasma-derived protein therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved...

08:30
VALENCIA, Calif., Feb. 07, 2017 /PRNewswire/ -- Bioness, Inc., the leading provider of cutting-edge, clinically supported rehabilitation therapies, today announced that it received clearance from the U.S. Food and Drug Administration (FDA) for the...

08:00
TORRANCE, Calif., Feb. 7, 2017 /PRNewswire/ -- Emmaus announced today the allowance of patent application number 2014-542296, by the Japanese Patent Office for the use of its lead investigative product, pharmaceutical grade L-glutamine (PGLG), for...


6 février 2017

18:39
SAN DIEGO, Feb. 6, 2017 /PRNewswire/ -- Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, announced today that the United States Food and Drug Administration (FDA) has granted 510(k)...

12:30
DURHAM, N.C., Feb. 6, 2017 /PRNewswire/ -- Baebies, a company focused on advancing newborn screening and pediatric testing, announced today it has received de novo clearance from the U.S. Food and Drug Administration (FDA) for SEEKER. SEEKER...

09:00
SAN FRANCISCO, Feb. 6, 2017 /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...


3 février 2017

17:41
BOSTON, Feb. 3, 2017 /PRNewswire/ -- Intarcia Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for active review its New Drug Application (NDA) for ITCA 650, an investigational therapy for the treatment...


2 février 2017

08:00
NORTH CHICAGO, Ill., Feb. 2, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for...

08:00
ABBOTT PARK, Ill., Feb. 2, 2017 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has authorized its molecular test, the Abbott RealTime ZIKA test, to detect Zika virus in whole blood (when collected...


1 février 2017

16:30
WARSAW, Ind., Feb. 1, 2017 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded 26-week efficacy claim...

09:15
NEW YORK, February 1, 2017 /PRNewswire/ -- Equashield, a leading provider of Closed System Transfer Devices (CSTDs) for the safe and simple handling of hazardous drugs, today announced the results of two comparative studies conducted at the...

08:38
TEL AVIV, Israel, February 1, 2017 /PRNewswire/ -- Patent Further Strengthens Company's IP position ahead of Planned New Drug Application to be Submitted to FDA Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative...

08:00
ABBOTT PARK, Ill., Feb. 1, 2017 /PRNewswire/ -- Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for both the Assurity MRItm pacemaker and the Tendriltm MRI pacing...

08:00
SAN FRANCISCO, Feb. 1, 2017 /PRNewswire/ -- Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, today...

08:00
BRIDGEWATER, N.J., Feb. 1, 2017 /PRNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Xyzal® Allergy 24HR as an over-the-counter (OTC) treatment for the relief of symptoms associated with seasonal and...


31 janvier 2017

14:09
INDIANAPOLIS, Jan. 31, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) in less than a 15-month period has granted a new and updated 510(k) clearance for two patented technologies made by NICO Corporation that are used in a new...


30 janvier 2017

17:26
DUBLIN, Jan. 30, 2017 /PRNewswire/ -- Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical has received final approval from the U.S. Food and Drug Administration for its New Drug...

07:59
DUBLIN, Jan. 30, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) to update the...

07:00
HOLON, Israel, January 30, 2017 /PRNewswire/ -- Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, today announced that the Company will host a conference call on Wednesday, February 15, 2017 at 10:00 AM EST to review fourth...