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 ed
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 ed
Clinical 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.