Le Lézard

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

19 mai 2017

13:05
The U.S. Food and Drug Administration has granted accelerated approval to a second drug in less than a month for first-line treatment for advanced bladder cancer ? again based on clinical trial findings from the same researcher from NYU Langone's...


18 mai 2017

09:00
Food safety company Agri-Neo today announced that its organic, non-thermal intervention, Neo-Pure, has been validated to achieve a 5-log pathogen reduction on raw nuts, including cashews, hazelnuts, macadamia nuts, and others. Among the companies...


17 mai 2017

17:00
A total of 13 abstracts across seven hard-to-treat cancers highlight the progress of avelumab as a monotherapy and potential novel combination treatment option   New data in metastatic Merkel cell carcinoma and previously treated metastatic...

16:02
The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the...

09:30
CrossBay Medical, Inc., today announced receipt of United States Food and Drug Administration (FDA) clearance of its product, the CrossBay IVF Embryo Transfer Catheter Set. The device has also received clearance to commercialize the product in Europe...

02:30
Bayer announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have...


16 mai 2017

16:59
Allergan Inc. is pleased to announce the Health Canada approval of VIBERZItm (eluxadoline) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. IBS-D patients suffer from frequent and urgent episodes of diarrhea, abdominal...

16:50
Abon Pharmaceuticals, LLC, a specialty pharmaceutical company, today announced that it has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Clofarabine Injection, 20 mg/20 mL, Single-use Vial. Clofarabine...

09:47
Smart Meter, LLC announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark in Europe to market the iGlucose® Blood Glucose Monitoring System. Aimed at improving health outcomes for people with...

09:42
This month, a new FDA commissioner was confirmed, a promising cancer drug delivered surprising clinical trial results, and China moved ahead of Western nations in human gene-editing experiments. Meanwhile, LabCorp completed a major acquisition and...

09:37
Pharmadax Inc., a pharmaceutical company based in New Taipei City, Taiwan, and its subsidiary Pharmadax USA, Inc., based in Irvine, California, today announced that U.S. Food and Drug Administration (FDA) has approved a generic equivalent to Seroquel...

07:30
Sangamo Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SB-525, the Company's clinical stage cDNA gene therapy candidate for hemophilia A, which is being developed as part of...

07:00
Allergan Inc. est heureux de vous informer de l'approbation de l'utilisation de VIBERZIMC (éluxadoline) par Santé Canada pour le traitement du syndrome du côlon irritable avec diarrhée (SCI-D) chez les adultes. Les patients atteints de SCI-D...

07:00
Allergan Inc. is pleased to announce the Health Canada approval of VIBERZItm (eluxadoline) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. IBS-D patients suffer from frequent and urgent episodes of diarrhea, abdominal...

06:52
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Levocetirizine Dihydrochloride Oral Solution, 2.5 mg/5 mL (0.5 mg/mL), the...


15 mai 2017

12:02
Body Vision Medical, a medical device company specializing in augmented real-time imaging, announced today that it has received clearance from the U.S. Food and Drug Administration to market LungVision, a novel imaging system that enables accurate...

09:35
Resverlogix Corp. ("Resverlogix" or the "Company") is pleased to announce the acceptance, by the Cardiovascular and Renal Products Division of the U.S. Food and Drug Administration (FDA), of  the Company's Investigational New Drug (IND) application...

08:00
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 initiate a Phase 1 study of GBR 1342, a humanized,...

07:36
Nuvo Pharmaceuticals Inc. (Nuvo or the Company) , a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities, today reported topline results from its multi-centre, randomized,...


12 mai 2017

12:54
The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their esophagus,...


11 mai 2017

08:00
Xencor, Inc. , a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, announced today that XmAb®5871 has been granted orphan drug...

07:00
Synthetic Biologics, Inc. , a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough...

06:00
NDS a annoncé aujourd'hui avoir reçu la notification préalable à la commercialisation 510(k) du FDA (Secrétariat américain aux produits alimentaires et pharmaceutiques) pour sa nouvelle solution ZeroWire® Mobile de socle d'écran alimenté par...

06:00
NDS today announced it has received FDA 510(k) clearance for its new ZeroWire® Mobile battery-powered display stand solution. Designed to enable the untethered clinical mobility of endoscopy displays, ZeroWire Mobile eliminates the display power...

03:01
The digital pathology industry just took another step forward, with the FDA clearance of a whole slide imaging (WSI) system (Philips IntelliSitetm Pathology Solution) for review of digital surgical pathology slides. Leica Biosystems congratulates...


10 mai 2017

12:44
NxStage Medical, Inc. , a leading medical technology company focused on advancing renal care, today announced that its next generation hemodialysis system has received FDA clearance.  This innovative system consists of new features and capabilities,...

08:00
Bridge Therapeutics, Inc., an innovative development-stage specialty pharmaceutical company, has announced that its CEO and Chief Scientific Officer Greg Sullivan, MD, will present at BioTrinity 2017 in London on Thursday, May 11....

05:46
Taiwan-based vaccine provider Adimmune (4142.TT) successfully obtained approval of its quadrivalent flu vaccine (ADIMFLU-S(QIS)) from Taiwan FDA. Adimmune will start the commercial production of quadrivalent flu vaccine in 2017 and supply the...

03:00
Bridge Therapeutics, Inc., an innovative development-stage specialty pharmaceutical company, has announced that its CEO and Chief Scientific Officer Greg Sullivan, MD, will present at BioTrinity 2017 in London on Thursday, May 11. BioTrinity is...


9 mai 2017

15:53
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection for the treatment of...

09:00
INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS), announced today that the FDA has approved its Exablate Neuro (Model 4000) system for use with 1.5T MRI in the non-invasive treatment of essential tremor (ET) in patients who have not...

07:00
Biscayne Neurotherapeutics, Inc., a clinical-stage company developing novel treatments for neurological disorders, today announced that lead compound BIS-001 has received an Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for...

06:30
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for the Resonatetm family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The approval includes new...


8 mai 2017

18:47
Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, a leading global eye health company, today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for brimonidine...

16:15
Novartis announced today that the US Food and Drug Administration (FDA) has approved the Kisqali® Femara® Co-Pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2...

13:55
BIOTRONIK today announced FDA approval of the company's MultiPole Pacing (MPP) technology, providing physicians with additional treatment options for heart failure patients who have been non-responsive to cardiac resynchronization therapy (CRT).1 MPP...

13:23
BIOTRONIK today announced FDA approval and the launch of Sentus ProMRI®, the thinnest quadripolar left ventricular lead available in the United States. This introduction completes BIOTRONIK's second-generation ProMRI lead portfolio, which also...

12:03
CurveBeam announced it has received FDA 510(k) clearance for the InReach, a Cone Beam CT imaging system primarily designed for the hand, wrist & elbow; & lower extremities in non-weight bearing position. The InReach is...

08:00
Atlanta-based company MagVenture Inc. can now add another FDA cleared medical device to its product portfolio. The technology behind is Transcranial Magnetic Stimulation, also known as TMS. It is indicated for the treatment of major depressive...

07:00
Oncolytics Biotech® Inc. (Oncolytics or the Company) announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation for REOLYSIN®, the Company's proprietary immuno-oncology viral agent, for the...


5 mai 2017

18:55
MT Pharma America, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted approval of RADICAVAtm (edaravone), as an intravenous infusion treatment for amyotrophic lateral sclerosis (ALS), a rapidly progressive neurodegenerative...

17:03
The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease. "After learning about the use of...


4 mai 2017

12:10
Spherix Global Insights recently released data collected from 257 rheumatologists in France, Germany, Italy, Spain and the UK, revealing a high unmet need for small molecules and alternate mechanism biologics for the treatment of rheumatoid arthritis...

09:00
Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today that it has released the new plasma hysteroscopic resection and vaporization full...


3 mai 2017

08:00
Luminex Corporation today announced that it has received FDA clearance for the ARIES® Bordetella Assay for direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in...

06:00
Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received US Food and Drug...


2 mai 2017

15:52
Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced approval of the VENTANA PD-L1 (SP263) Assay by the US Food and Drug Administration (FDA) as a complementary diagnostic3 to provide PD-L1 status for patients with locally advanced or metastatic...

07:00
BioDelivery Sciences International, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) revising the indication to...


1 mai 2017

15:52
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to IMFINZItm (durvalumab). IMFINZI is indicated for the treatment of...

10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new, dedicated high-volume testing immunoassay solution for the cobas 8000 modular analyzer series, the cobas e 801 module, has received 510(k) clearance from the U.S. Food and Drug...