Le Lézard

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

5 juin 2017

10:00
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 care professionals use the CMV test to assess...

09:00
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 FLXfittm15, enhancing the already successful FLXfittm...

07:30
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 oncology expert and recently retired Novartis...


2 juin 2017

07:30
Mylan N.V. today announced the U.S. launch of Zoledronic Acid Injection, 5 mg/100 mL Single Dose Vial, a generic version of Novartis' Reclast® Injection. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its...

07:00
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 Administration's (FDA) accelerated approval of...


1 juin 2017

14:24
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 dose vial containing 50 mg per 2mL (25mg/mL) and...

10:05
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 inhibition can help shrink tumors in some ALK-positive...

09:00
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 molecular diagnostics instrument.  GenePOC, Inc. (GenePOC) a member of...

09:00
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 l'instrument de diagnostic moléculaire, le revogene. ...

07:00
- Genentech has submitted all three solid tumor trials planned underits cancer immunotherapy collaboration with BioLineRx -  - Studies will investigate the combination in pancreatic cancer, gastric cancer and non-small cell lung cancer...


31 mai 2017

17:32
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 treatment of adults and children with hemophilia...

16:05
Jazz Pharmaceuticals plc 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  VYXEOStm (cytarabine and daunorubicin) liposome injection,...

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...