Le Lézard

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

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8 juin 2017

16:30
SAN DIEGO, June 8, 2017 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan...

09:00
TORONTO, June 8, 2017 /PRNewswire/ -- Thornhill Medical, has received notification from the US FDA that the MOVES® SLCtm Portable Emergency Life Support System has received 510K clearance. This approval expands the capabilities of the current MOVES®...

09:00
GERMANTOWN, Md. and HILDEN, Germany, June 8, 2017 /PRNewswire/ -- QIAGEN N.V. (NASDAQ: QGEN) (Frankfurt Prime Standard: QIA) today announced the U.S. regulatory approval of QuantiFERON®-TB Gold Plus (QFT®-Plus) the fourth generation of the market...


7 juin 2017

15:17
MINNETONKA, Minn., June 7, 2017 /PRNewswire/ -- MedNet Solutions, an innovative cloud-based eClinical technology company that supports the entire spectrum of clinical research, is pleased to announce they will preview the latest release of iMedNettm,...

11:30
CHICAGO, June 7, 2017 /PRNewswire/ -- Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that its development partnership with a leading medical products company has resulted in the...

09:00
THOUSAND OAKS, Calif., June 7, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE: AGN) today announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the Biologics...

08:00
MARLBOROUGH, Mass., June 7, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) announced today that the Geniustm 3D Mammographytm exam is now the only mammogram that is FDA-approved as superior to standard 2D mammography for routine breast cancer...

08:00
The Canadian Cancer Survivor Network and Lung Cancer Canada are calling on government and industry to help accelerate negotiations OTTAWA, June 7, 2017 /CNW/ - On behalf of patients living with lung cancer and their loved ones, the Canadian Cancer...

06:00
SAN FRANCISCO, June 7, 2017 /PRNewswire/ -- Eko Devices ("Eko"), the leader in mobile acoustic cardiac monitoring tools, has received FDA clearance to market its latest innovation, DUO ? a combined digital stethoscope and electrocardiogram (ECG). The...


6 juin 2017

08:30
SOMERVILLE, N.J., June 6, 2017 /PRNewswire/ -- Uncontrolled bleeding during surgery can adversely affect patient outcomes, hospital costs and resources.1-9 Primary methods of hemostasis alone may be ineffective or impractical,10 and it is...

08:00
SOUTH PLAINFIELD, N.J., June 6, 2017 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Peripheral and Central Nervous...

05:30
HONG KONG, June 6, 2017 /PRNewswire/ -- Announcement marks company's official entry into the US market  OrbusNeich, a global company specializing in the provision of life-changing vascular solutions, has announced the launch of its world-renowned...

05:30
Announcement marks company's official entry into the US market  HONG KONG, June 6, 2017 /CNW/ - OrbusNeich, a global company specializing in the provision of life-changing vascular solutions, has announced the launch of its world-renowned Sapphire...

05:30
HONG KONG, June 6, 2017 /PRNewswire/ -- Cette annonce marque l'entrée officielle de l'entreprise sur le marché des États-Unis    OrbusNeich, une entreprise mondiale spécialisée dans la fourniture de solutions vasculaires pour l'amélioration de la...

02:00
GERMANTOWN, Md. and HILDEN, Germany, June 6, 2017 /PRNewswire/ -- QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received premarket approval from the U.S. Food and Drug Administration (FDA) for its automated artus®...


5 juin 2017

16:30
IRVINE, Calif., June 5, 2017 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received U.S. Food and Drug...

15:32
SILVER SPRING, Md., June 5, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a...

10:00
PLEASANTON, Calif., June 5, 2017 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for the cobas® CMV (cytomegalovirus) test for use on the fully automated cobas® 6800 and cobas® 8800 Systems. Health...

09:00
OR AKIVA, Israel, June 5, 2017 /PRNewswire/ -- Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced CE mark of the...

07:30
JERUSALEM, June 5, 2017 /PRNewswire/ -- Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today the appointment of Nobel Prize Laureate Professor Roger Kornberg and immune...


2 juin 2017

07:30
HERTFORDSHIRE, England and PITTSBURGH, June 2, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Zoledronic Acid Injection, 5 mg/100 mL Single Dose Vial, a generic version of Novartis' Reclast® Injection....

07:00
BALTIMORE, June 2, 2017 /PRNewswire/ -- Personal Genome Diagnostics Inc. (PGDx), a pioneer in cancer genomic testing, today highlighted its patent-pending microsatellite instability (MSI) testing technology following the U.S. Food and Drug...


1 juin 2017

14:24
VERNON HILLS, Ill., June 1, 2017 /PRNewswire/ -- Nexus Pharmaceuticals announced today the immediate availability in the United States of Sodium Nitroprusside Injection. Nexus Pharmaceuticals' Sodium Nitroprusside Injection is available as a single...

10:05
TUCSON, Ariz., June 1, 2017 /PRNewswire/ -- More than 1.6 million people die globally from lung cancer each year.1 ALK ? anaplastic lymphoma kinase ? is an important biomarker found in non-small cell lung cancer (NSCLC). Its detection and...

09:00
QUÉBEC CITY and LAUSANNE, Switzerland, June 1, 2017 /PRNewswire/ -- GenePOC announces it received 510(k) clearance from the US Food and Drug Administration to market its first molecular assay to detect Group B Streptococcus and for the revogene...

09:00
QUÉBEC et LAUSANNE, Suisse, June 1, 2017 /PRNewswire/ -- GenePOC annonce l'homologation 510(k) de la part de la Food and Drug Administration des États-Unis pour la commercialisation de son premier test bactériologique, le GenePOC GBS LB, ainsi que...

07:00
TEL AVIV, Israel, June 1, 2017 /PRNewswire/ -- - Genentech has submitted all three solid tumor trials planned underits cancer immunotherapy collaboration with BioLineRx -  - Studies will investigate the combination in pancreatic...


31 mai 2017

17:32
PLAINSBORO, N.J., May 31, 2017 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the...

16:05
DUBLIN, May 31, 2017 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for...

11:15
HOUSTON, May 31, 2017 /PRNewswire/ -- OrthoAccel® Technologies, Inc., the leader in accelerated orthodontics, today announced that it has received FDA clearance for its newest accelerated treatment device, AcceleDent® Optima, and will begin...


30 mai 2017

16:36
SILVER SPRING, Md., May 30, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult...

11:37
WHIPPANY, N.J., May 30, 2017 /PRNewswire/ -- Bayer today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for myBETAapptm and the BETACONNECT Navigatortm....

05:00
VALLETTA, Malta, May 30, 2017 /PRNewswire/ -- People.cn recently launched a report on Feihe awarded the 2017 "Monde Selection" champion. The full report is as follow: The 2017 award ceremony for "Monde Selection" is held on May 29 in Valletta, the...

04:00
LA VALETTE, Malte, 30 mai 2017 /PRNewswire/ -- People.cn a récemment lancé un rapport indiquant que Feihe avait remporté le prix « Monde Selection » 2017. Le rapport intégral est disponible ci-dessous : La cérémonie du prix « Monde Selection » 2017...


26 mai 2017

16:02
EAST HANOVER, N.J., May 26, 2017 /PRNewswire/ -- Novartis today announced the US Food and Drug Administration (FDA) approved the expanded use of Zykadia® (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung...

11:15
DUBLIN, May 26, 2017 /PRNewswire/ -- Research and Markets has announced the addition of the "PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation" conference to their offering. The European Medicines...

11:00
DUBLIN, May 26, 2017 /PRNewswire/ -- Research and Markets has announced the addition of the "Quality Control Laboratory Compliance - cGMPs and GLPs: One and a Half-day In-person Seminar" conference to their offering. FDA inspection and oversight...


24 mai 2017

16:05
LA JOLLA, Calif., May 24, 2017 /PRNewswire/ -- Privately-held CalciMedica, Inc., announced today that it received Fast-Track designation from the U.S. Food and Drug Administration (US FDA) for its lead clinical compound, CM4620, a novel, calcium...

12:43
BUFFALO, N.Y., May 24, 2017 /PRNewswire/ -- Athenex, Inc., Buffalo, NY, a global specialty oncology pharmaceutical company focusing on the development and commercialization of next generation therapies for cancers and supportive therapies, announced...

09:01
CARLSBAD, California, May 24, 2017 /PRNewswire/ -- Applied Spectral Imaging (ASI), a global leader in computer-assisted image analysis platforms, introduces HiPath for analysis of PD-L1 assays. HiPath, ASI's advanced IHC platform, is a pioneer in...

08:03
MUMBAI, India and PRINCETON, N.J., May 24, 2017 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries or associate companies) announces the U.S....


23 mai 2017

19:35
BETHPAGE, N.Y., May 23, 2017 /PRNewswire-USNewswire/ -- In an unprecedented, fast-tracked review, the Food and Drug Administration (FDA) approved the use of pembrolizumab (anti-PDI) immunotherapy for patients with advanced pancreatic cancers who have...

16:14
SILVER SPRING, Md., May 23, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the...

06:30
PBI-4050 monotherapy and combination with nintedanib demonstrated promising results in the treatment of Idiopathic Pulmonary Fibrosis (IPF) Data on PBI-4050 regulation of proteins involved in human lung fibrosis Plasminogen administration shown to...

06:30
Le PBI-4050 en monothérapie et en combinaison avec le nintedanib démontre des résultats prometteurs pour le traitement de la fibrose pulmonaire idiopathique (FPI) Données sur la régulation par le PBI-4050 des protéines impliquées dans la fibrose...


22 mai 2017

17:47
PARIS and TARRYTOWN, N.Y., May 22, 2017 /PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) approval of Kevzara® (sarilumab) for the treatment of adult patients with moderately to...

17:45
TARRYTOWN, N.Y. and PARIS, May 22, 2017 /PRNewswire/ -- Kevzara is now available to U.S. patients Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) approval of Kevzara®...

13:19
EL DORADO HILLS, Calif., May 22, 2017 /PRNewswire/ -- EMED Technologies Corporation is pleased to announce the SCIg60 Infusion System has been granted expanded indications as the only Immune Globulin Subcutaneous (Human) mechanical pump infusion...

11:12
SILVER SPRING, Md., May 22, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first...

05:32
WASHINGTON, May 22, 2017 /PRNewswire-USNewswire/ -- Biologics Prescribers Collaborative (BPC) applauds the U.S. Food and Drug Administration (FDA) for its careful consideration of interchangeability in its draft guidance. As FDA continues to develop...

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