Sentences with phrase «drug administration approval»

It is the only hormonal IUD that has the Food and Drug Administration approval.

Food and Drug Administration approval of a medication assures the consumer and the prescribing veterinarian that the product meets certain safety and efficacy standards.

Zoetis announced the U.S. Food and Drug Administration approval of APOQUEL on May 16, 2013.

Next Page: For those who can't sleep through the night [pagebreak] For those who can't sleep through the night In the pipeline: U.S. Food and Drug Administration approval is pending for Intermezzo, a new medication to help insomnia sufferers fall back to sleep when they wake up in the middle of the night.

Food and Drug Administration approval does not confirm that the drug is the most effective or the safest drug for you.

Kite reportedly intends to seek U.S. Food and Drug Administration approval this spring and approval in Europe later this year.

Dr. Locke participated in the clinical trials that led to US Food and Drug Administration approval of a novel chimeric antigen receptor (CAR) T - cell therapy called axicabtagene ciloleucel.

University of Pennsylvania immunotherapy researcher Dr. Carl June, who led the development of an experimental therapy for advanced childhood leukemia that is expected to become the first CAR T - cell therapy to win U.S. Food and Drug Administration approval, will give the keynote talk today at the Conference on Cell & Gene Therapy for HIV Cure at Fred Hutchinson Cancer Research Center.

Last week, for example, a 2010 study spearheaded by another Gladstone HIV / AIDS scientist — Robert Grant, MD, MPH — culminated in Food & Drug Administration approval for Truvada, the first FDA - approved medication for HIV prevention.

«Agents that block the proteins — CDK4 / 6 inhibitors — have received Food and Drug administration approval for some patients with metastatic breast cancer, but they've also shown promise against others types of tumors in clinical trials.

That could make it more challenging to get the therapy ready for human trials and Food and Drug Administration approval, Chen says.

Da Vinci, which costs about $ 2 million and received U.S. Food and Drug Administration approval in 2000, allows surgeons to manipulate laparoscopic instruments and an endoscopic camera attached to four robotic arms.

The researchers indicate that their ultimate goal is to position this technology for Food and Drug Administration approval.

Strong results from the other arm of CoreValve's U.S. Pivotal Trial with patients at extreme risk for standard aortic valve - replacement surgery were reported in October and led to Food and Drug Administration approval for the device in this population.

Nitromed was pushing for Food and Drug Administration approval to market the drug.

Outside of the United States, Australia, and Kenya, few places aggressively promote this proven prevention strategy that won U.S. Food and Drug Administration approval in 2012.

They have filed patents on the technology, and within a couple of years hope to have Federal Drug Administration approval for the BiliCam app that parents can use at home on their smartphones.

Only one such treatment has so far received Food and Drug Administration approval (a therapy to treat bladder cancer), though others are in the pipeline.

Plasma is given routinely to patients, so trials of this approach, unlike those testing a new protein, would not require U.S. Food and Drug Administration approval, Wyss - Coray says.

(They would have to go through numerous clinical trials and get U.S. Food and Drug Administration approval before anyone could use them, for example, to carry insulin for diabetics or deliver drugs that could open clogged arteries.)

Although prototypes exist, sensor technology and U.S. Food and Drug Administration approval are needed.

That means fewer sales per drug — but genetic tests should make clinical trials cheaper and faster, and a higher percentage of trials should lead to U.S. Food and Drug Administration approval — assuming FDA can keep pace.

* Update: On April 6 Medtronic announced that its Micra Transcatheter Pacing System had become the first leadless pacemaker to receive U.S. Food and Drug Administration approval.

«In the 20 years that I've been in practice, I consider this a major milestone,» she adds, noting that the trial results helped achieve U.S. Food and Drug Administration approval in March to treat such patients whose lung cancer progressed, despite standard chemotherapy.

TouchNetworks is still seeking Food and Drug Administration approval for the medical vest, a process that could delay its medical use for several years.

The company has attained U.S. Food and Drug Administration approval for its Aseptic Combi Predis blow fill seal filler.

But it has yet to seek Food and Drug Administration approval for its «silk biopolymer platform for encapsulating and stabilizing biological compounds.»

U.K. - based GW Pharmaceuticals, which is extracting CBD from the cannabis plant to make anti-seizure medication that is in the Food and Drug Administration approval pipeline, already has an import - export licenses for marijuana.

Other changes announced on Friday include allowing US companies to provide safety - related services for commercial aircraft in Cuba, where US airlines are beginning regularly scheduled flights, and allow Cuban pharmaceutical companies to apply for US Food and Drug Administration approval.

Align Technology Announces China Food and Drug Administration Approval for the iTero Element Intraoral Scanner

Sarepta Therapeutics, which won a pioneering Food and Drug Administration approval for its Duchenne muscular dystrophy drug last year, has settled a patent dispute with rival BioMarin over the «exon - skipping» technology at heart of the companies» muscular dystrophy treatments.

Last year, Chinese pharmaceuticals obtained U.S. Food and Drug Administration approvals for 38 generic drugs, up from 22 such approvals in 2016.

Not exact matches

British drug giant GlaxoSmithKline won a critical Food and Drug Administration (FDA) approval for its landmark HIV treatment Juluca — the first HIV drug cocktail to contain just two medicines rather than three or mdrug giant GlaxoSmithKline won a critical Food and Drug Administration (FDA) approval for its landmark HIV treatment Juluca — the first HIV drug cocktail to contain just two medicines rather than three or mDrug Administration (FDA) approval for its landmark HIV treatment Juluca — the first HIV drug cocktail to contain just two medicines rather than three or mdrug cocktail to contain just two medicines rather than three or more.

The Food and Drug Administration (FDA) on Tuesday gave Swiss drug giant Novartis a second approval for its pioneering CAR - T cancer therapy, which uses patients» own immune cells (re-engineered outside the body and then replicated) to destroy blood cancDrug Administration (FDA) on Tuesday gave Swiss drug giant Novartis a second approval for its pioneering CAR - T cancer therapy, which uses patients» own immune cells (re-engineered outside the body and then replicated) to destroy blood cancdrug giant Novartis a second approval for its pioneering CAR - T cancer therapy, which uses patients» own immune cells (re-engineered outside the body and then replicated) to destroy blood cancers.

In 2011, Restoration Robotics got approval from the U.S. Federal Drug Administration to begin commercial operations with its Artas System, which uses digital imaging and a robotic arm to help with the hair transplant procedure.

The Food and Drug Administration (FDA) under Commissioner Scott Gottlieb is continuing its quest to ramp up generic drug approvals, this time for complex generics that could compete with products such as Mylan's EpiDrug Administration (FDA) under Commissioner Scott Gottlieb is continuing its quest to ramp up generic drug approvals, this time for complex generics that could compete with products such as Mylan's Epidrug approvals, this time for complex generics that could compete with products such as Mylan's EpiPen.

The biotech received Food and Drug Administration (FDA) approval for its drug to treat the rare blood cancer acute myeloid lymphoma (AML), which will be marketed as Idhifa, on TuesDrug Administration (FDA) approval for its drug to treat the rare blood cancer acute myeloid lymphoma (AML), which will be marketed as Idhifa, on Tuesdrug to treat the rare blood cancer acute myeloid lymphoma (AML), which will be marketed as Idhifa, on Tuesday.

The Food and Drug Administration (FDA) is crafting a special unit to focus on digital health and tackle thorny issues such as creating an appropriate approval / clearance pathway for mobile medical apps.

The company has received approval from the Food and Drug Administration to test for carrier status of 36 genetically - transmitted conditions.

A panel of experts which advises the Food and Drug Administration (FDA) has unanimously voted to recommend approval of a pioneering cancer therapy from Novartis, setting up a likely approval for the first - of - its - kind treatment.

On Wednesday, Swiss pharmaceutical giant Novartis made history as the first company to win Food and Drug Administration (FDA) approval for a groundbreaking new type of cancer treatment known as CAR - T.

British pharma giant GlaxoSmithKline (GSK) has won a critical Food and Drug Administration (FDA) approval for Shingrix, a new and improved version of the shingles vaccine.

Second, approval rates by the U.S. Food and Drug Administration have steadily risen over the past two decades, climbing from 23 percent in 1994 to 89 percent and 77 percent in 2014 and 2015, respectively.

Nootropics, because they are supplements, do not require approval from the U.S. Food and Drug Administration.

SAN JOSE, Calif., April 25, 2018 (GLOBE NEWSWIRE)-- Align Technology, Inc. (NASDAQ: ALGN) today announced that the company has received approval from the China Food and Drug Administration (CFDA) to market the iTero Element intraoral scanner in China.

The bill aims to speed up the approval for drugs and medical devices through a variety of tweaks to the Food and Drug Administration (FDA).

That led to an earlier Food and Drug Administration (FDA) approval for Keytruda than Opdivo in 2014 since the former was a more targeted therapy; but it also left Merck with a smaller slice of the market.

For many years, Theranos had the backing of third parties like these, including approval from the Food and Drug Administration to test for herpes and Ebola.

The Food and Drug Administration (FDA) continued its potentially record - breaking pace of new drug approvals Thursday, green lighting the first - ever «biosimilar» copycat of a cancer dDrug Administration (FDA) continued its potentially record - breaking pace of new drug approvals Thursday, green lighting the first - ever «biosimilar» copycat of a cancer ddrug approvals Thursday, green lighting the first - ever «biosimilar» copycat of a cancer drugdrug.

The Food and Drug Administration (FDA) wasn't resting on its laurels in 2017: The agency under new commissioner Scott Gottlieb approved 46 new medicines — i.e., completely new therapies, not just additional indications on already - approved drugs — the highest number of approvals in more than two decades.