Le Lézard

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

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31 mai 2017

11:15
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 fulfilling orders immediately. The next...


30 mai 2017

16:36
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 patients. Apotex Inc., Teva...

11:37
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. With this software in...

05:00
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 capital of Malta. The high-end infant milk...

04:00
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 s'est tenue le 29 mai à La Valette, la capitale...


26 mai 2017

16:02
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 cancer (NSCLC) whose tumors are anaplastic...

11:15
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 Agency's (EMA) Guideline on good...

11:00
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 of quality control (QC) laboratories...


24 mai 2017

16:05
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 release-activated calcium (CRAC) channel inhibitor,...

12:43
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 today that its partner, Guangzhou Xiangxue...

09:01
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 digital pathology solutions that support PD-L1...

08:03
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. Food and Drug Administration (FDA) acceptance of the Biologics...


23 mai 2017

19:35
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 a defect in their capacity to repair DNA.  Support from...

16:14
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 agency has approved a cancer treatment based on a common...

06:30
Prometic Life Sciences Inc. ("Prometic" or the...

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
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 severely active rheumatoid arthritis (RA) who have had an...

17:45
Kevzara is now available to U.S. patients Regeneron Pharmaceuticals, Inc. and Sanofi today announced the U.S. Food and Drug Administration (FDA) approval of Kevzara® (sarilumab) for the treatment of adult patients with moderately to severely active...

13:19
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 system cleared by the U.S. FDA. The FDA 510(k) issuance...

11:12
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 FDA-approved therapy, specific to this type of vasculitis....

05:32
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 the draft guidance, BPC urges the agency to promote...


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...

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