Sentences with phrase «approved for clinical»

Our programs, when applicable, have been reviewed and approved for clinical Category I (preapproved) CME credit by the American Academy of Physician Assistants.
A standardized commercial version of human anti-CTLA-4 antibodies was approved for clinical use in 2011; over 30,000 cancer patients now have received the new immunotherapy.
Importantly, because it is already approved for clinical use, amiodarone HCL may have clinical applications in cell replacement therapies by selectively removing only the unwanted undifferentiated NSCs during the pre-transplant period.
Whole genome sequencing is performed on the Illumina HiSeq X Ten platform, which is CAP / CLIA approved for clinical use.
Biodegradable BCNU polymer implants are approved for clinical trials, conducted by Cancer Center investigators, in brain tumor patients.
While TSA is expensive to produce and it is not approved for clinical use, similar drugs being developed to treat cancer and other diseases may be useful for treating SMA, Dr. Sumner says.
«On its 10th birthday, the California Institute for Regenerative Medicine celebrated 10 stem cell therapies that have been approved for clinical trials, including an HIV / AIDS trial at City of Hope,» the message read.
«To date, neither antiviral drugs nor vaccines are approved for clinical use against human parainfluenza virus, which reinforces the urgent need for new therapeutic discovery strategies.
It was approved for clinical use in Europe in 2012.
Fructosamine is approved for clinical use in the United States but rarely used.
Many of the early problems that hindered the clinical applications of particulate DDS have been overcome, with several DDS formulations of anticancer and antifungal drugs now approved for clinical use.
«Ga - 68 DOTATOC and similar agents are investigational drugs in the United States and are not yet approved for clinical use,» said Menda.
Recently introduced and not currently approved for clinical use, cinematic rendering produces images akin to a photograph of a 3D model.
As these compounds are already approved for clinical trails in pediatric brain tumors, these findings suggest that drugs inhibiting MEK activity could offer a new therapy option for children with these devastating tumors.
The concept of liposomal drug delivery has revolutionised the pharmaceutical field and came into praxis some 20 years ago when the first liposomal formulation of the anti-cancer drug doxorubicin was approved for clinical use.
Ascentage, founded in 2010, has seven products in clinical development and 17 in total approved for clinical studies in China, the United States and Australia.

Not exact matches

In 2017, Arterys's cardiac MRI technology, which examines the heart and blood flow through its ventricles, became the first cloud - based AI platform to be FDA - approved for use in clinical settings.
The treatment was approved for the devastating rare disease Duchenne muscular dystrophy but created major divisions within the FDA because it simply hadn't demonstrated a whole lot of efficacy, meaning the pricey therapy is essentially being subjected to a real - world clinical test.
Intarcia has completed several late - stage clinical trials in which it uses the pump to deliver a glucose - controlling drug continuously for months — an idea, that if successful (and approved by the FDA) could significantly help patients with type 2 diabetes, fewer than half of whom maintain the recommended glycemic levels.
The FDA and Flatiron Health have been collaborating to explore how the FDA might be able to use real - world data (that clinical information Flatiron collects) to inform how drugs the agency approves are used outside of the clinical trials that are the basis for their approval.
«We didn't have a specific reversal strategy for these drugs, and I think that left people feeling a bit insecure,» added Pollack, who has done clinical work on a recently approved antidote to Boehringer Ingelheim's rival blood clot preventer Pradaxa.
We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.
Lilly outlined in July a likely multi-year delay for its experimental rheumatoid arthritis drug baricitinib, after the U.S. Food and Drug Administration declined to approve the drug, calling for an additional clinical study.
• Health Canada has approved Sunfiber for use as a dietary fiber source, based on clearly demonstrated safety and clinical evidence that the addition of Sunfiber to foods, results in more than 20 percent reduction in postprandial blood glucose levels.
Although a considerable body of scientific evidence substantiates the positive correlation between curcumin consumption and a reduction in the risk of cancer, the paucity of suitably designed human clinical trials that clearly demonstrate any direct effect of curcumin on cancer markers may prevent Health Canada from approving a cancer risk reduction claim for curcumin within the current regulatory framework.
The Clinical Forehead Thermometer is a popular model, perhaps because it's considered to be medical grade and has been approved for home use by the FDA.
He serves on the House Energy and Commerce Committee's Health Subcommittee, and last year he authored a section of important health legislation that speeds the process for new drugs to be approved through clinical trials.
«Since edelfosine is already FDA - approved, we want to try and move this compound into a phase II clinical study for metastatic brain cancer in the next few years.»
They discovered edelfosine, which has been FDA - approved as an investigational leukemia treatment, and has also been used in clinical research for primary brain tumors.
The FDA reviews more liver health data and approves duloxetine for depression and diabetic neuropathy (pain), based on another set of clinical trials.
Several JAK2 inhibitors have already been approved by the FDA or are currently in clinical trials for the treatment of other cancers.
AAV is in use in many late - stage clinical trials in the United States, and has already been approved for use in one gene therapy drug in the European Union.
Previously, Russo oversaw international clinical trials for Sativex, an oral spray made by GW Pharmaceuticals in Salisbury, U.K., that has been approved in 27 countries for treating spasticity caused by multiple sclerosis and in Canada for certain types of pain.
Through the project, researchers analyze the mutational landscape of each patient's tumor and suggest clinical trials or approved drugs that might be appropriate for that patient, according to Chinnaiyan.
Two of the drugs are investigational and approved by the Food and Drug Administration (FDA) for use in people as part of clinical trials; the third drug is FDA - approved to treat rheumatoid arthritis.
The drug is not approved for weight management, according to its manufacturer, Denmark - based Novo Nordisk, which sponsored this study, called the SCALE ™ (Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic and Diabetic Subjects) Obesity and Prediabetes trial.
In an interview in the spring of 2015, Damiano confidently predicted: «We're going to be running a pivotal trial by the end of the year,» referring to the type of clinical trial designed specifically to meet the FDA's standards for getting a device approved.
The CRISPR / Cas9 platform for Duchenne developed by the UCLA scientists is not yet available in clinical trials and has not been approved by the FDA for use in humans.
Hamburg noted that «I reviewed and thoughtfully considered the data, clinical information, and analysis provided by» FDA's drug experts, «and I agree... that there is adequate and reasonable, well - supported, and science - based evidence that Plan B One - Step is safe and effective and should be approved for nonprescription use for all females of child - bearing potential.»
With a dearth of approved drug therapies for NAFLD, lifestyle changes remain the cornerstone of clinical care.
In a randomized, controlled clinical trial — the first of its kind — a multi-institution research team reports that daptomycin, part of a new class of antibiotics currently approved only for use in adults, is effective and well - tolerated in children.
In 1999 the FDA approved the material for clinical use, and soon surgeons across the nation began using it on patients to repair rotator cuffs, abdominal hernias, and esophageal reflux damage, and even to induce the regrowth of the outer lining of the brain.
In the past year, the South Korean Food and Drug Administration (FDA) has approved the world's first three stem - cell treatments — Hearticellgram - AMI, Cupistem and Cartistem — which followed on the heels of clinical tests for human embryonic stem - cell therapies approved in 2010, according to the health ministry.
A separate downside is that patients who have unapproved and unproven stem cell interventions decrease their chances of qualifying for FDA - cleared and IRB - approved clinical trials that comply with federal regulations.
This improvement could be a significant result, as there are currently no approved pharmaceutical therapies for traumatic brain injury (TBI), and recently completed clinical trials have not demonstrated any benefit of other tested neuro - protective interventions.
Decitabine is approved by the U.S. Food and Drug Administration to treat myelodysplastic syndromes and leukemia, and for use in clinical trials for several types of solid - tumour cancers including colorectal.
«However, given that IGF - 1 is approved for human use in people who are deficient in this hormone, a clinical trial of IGF - 1 in lithium - resistant bipolar disorder patients is warranted.»
In March last year, the FDA approved Perin's request to conduct the country's first advanced, randomized, double - blind clinical trial of stem cells for heart failure.
Flibanserin was approved by the FDA on its third attempt, but the agency's clinical reviewers recommended that it be rejected, wrote Drs. Steven Woloshin and Lisa Schwartz, of The Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, New Hampshire, in an edclinical reviewers recommended that it be rejected, wrote Drs. Steven Woloshin and Lisa Schwartz, of The Dartmouth Institute for Health Policy and Clinical Practice in Lebanon, New Hampshire, in an edClinical Practice in Lebanon, New Hampshire, in an editorial.
The immunotherapy drug pembrolizumab — already FDA - approved for other forms of cancer - has been found to be effective in patients with metastatic triple negative breast cancer, according to an international clinical trial led by NYU Langone's Perlmutter Cancer Center.
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