Sentences with phrase «no treatment approved»

«This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.»

SRSE accounts for about 25,000 to 41,000 cases each year in the United States and there are currently no treatments approved by the U.S. Food and Drug Administration for the disorder, Sage said.

The treatment approved came after Suffolk water ran a pilot test in 2017.

CANCER CRUSH In CAR - T cell therapy, a cancer treatment approved by the FDA this year for certain blood cancers, a patient's T cells (teal) are genetically modified to hunt down and kill cancer cells (blue).

There are no vaccines or treatments approved by the Food and Drug Administration for treating these viruses.

The causes are unknown, although there may be genetic roots; there are no cures and no treatments approved by the Food and Drug Administration.

At present, there are no embryonic stem - cell treatments approved by the US Food and Drug Administration, and most human studies of such therapies have shown unremarkable results.

In fact, Finasteride is only one of the two hair loss treatments approved by FDA.

Oclacitinib is the newest treatment approved for treating canine atopic dermatitis for patients at least 12 months old.

Medications, physiotherapy, and any other treatments approved by your insurance company can be included.

Not exact matches

Consider: Last year alone, the FDA approved two treatments, from Novartis and Gilead, that literally reengineer patients» immune T - cells to target and destroy blood cancers.

The FDA has approved a four - week dosing schedule for Bristol - Myers Squibb's cancer immunotherapy treatment Opdivo, doubling the current two - week schedule for a variety of cancers.

The Food and Drug Administration delivered a boon to U.S. drug giant Johnson & Johnson on Thursday, approving the company's psoriasis treatment Tremfya (a psoriasis drug that analysts say could wring in billions of dollars in annual sales).

The degenerative condition has no cure and only two treatments on the U.S. market — including one that was approved just earlier this year.

Treatments simply address symptoms, and there hasn't been a new Alzheimer's drug approved in more than a decade.

Shkreli's basic modus operandi in the biopharma sphere was to take niche drugs in treatment spaces where U.S. patients have few options (although those medicines may very well have been approved and available in other countries) and bring them to market, after which he'd maintain carte blanche on the products» prices.

But before his arrest, he said he'd use KaloBios as a vehicle to nab another niche drug, this time for treatment of the parasitic infection Chagas disease, and dramatically increase its price to the $ 60,000 to $ 100,000 range after helping it win FDA approval (the drug is approved in other countries and is provided to patients in the U.S. on a special and selective basis).

Dr. Nir Barzilai, the director of Institute for Aging Research at the Albert Einstein College of Medicine in New York, has been researching the drug, with the hopes of one day getting it approved as an anti-aging treatment by the FDA.

The treatment, named Kymriah, was hailed by doctors and the life sciences community as a major advance in medicine and a boon to children and young adults with a certain form of leukemia (the group for whom the gene therapy is approved).

The plan also calls for generic versions of any drug or treatment to be available as soon as the Food and Drug Administration approves it.

«We believe that when this treatment is approved it will save thousands of children's lives around the world,» said Tom Whitehead, the father of a 12 - year - old who is now cancer - free after receiving CTL019.

As I've chronicled extensively, Exondys is an extremely controversial treatment, and the FDA's decision to approve the therapy over the objections of the agency's own scientific staff stunned many observers last year, raising questions about whether or not the FDA had succumbed to a well - orchestrated and heart - wrenching PR campaign by patients and advocates.

Another recently approved one - time therapy, Novartis» Kymriah for a form of leukemia, also has an outcomes - based pledge: If the treatment isn't working after a month, Novartis doesn't get paid.

Two days after the FDA approved Addyi, the first medication to treat female sexual dysfunction, Valeant bought Sprout Pharmaceuticals, the makers of the treatment.

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.

The memory - eating disease, expected to afflict 15 million Americans by 2060 (and tens of millions more around the world as life expectancy increases), has no cure; a new drug for the condition hasn't been approved in well over a decade; initially promising experimental treatments seem to be failing with clockwork regularity; and there's not even a definitive consensus on what, exactly, biopharma companies should focus on while developing Alzheimer's medicines.

That means the treatment could be approved on or before January 12, 2018, which would make it the first - ever gene therapy cleared to treat a genetic condition in the U.S..

The growing number of people who have the disease is troubling, because there are only four approved drugs that treat symptoms of the disease, and several hopeful treatments have failed key studies in 2017.

The FDA has declined to approve biotech Amgen's experimental romosozumab, a treatment for osteoporosis.

For instance, just last month, the Food and Drug Administration (FDA) approved ViiV's Juluca, the first - ever treatment for HIV - 1 that contains just two drugs (rather than the three or more involved in most HIV therapy cocktails).

U.S. regulators this week approved the first drug for a new type of cancer treatment, confirming a theme some stock pickers have found in biotech.

The findings suggest that the therapies aren't used quite like how they're approved by the FDA, which could make a difference in how the treatments pan out.

The FDA could approve the treatment as soon as February.

Viagra was the first treatment for erectile dysfunction, but that isn't what it was originally approved for.

GlaxoSmithKline's Strimvelis, which provides a cure for a fatal immune deficiency, is a treatment now approved in Europe.

The much - maligned (and financially hobbled) Valeant Pharmaceuticals got a spark of good news Wednesday as the FDA approved its Siliq (brodalumab), a treatment for moderate - to - severe plaque psoriasis.

The FDA just approved a blood cancer treatment that stimulates the immune system to fight off cancerous cells.

Earlier this month, the FDA approved two other treatments for multiple myeloma, including another kind of monoclonal antibody drug (the same class of drug that elotuzumab is in).

The treatment, Mitsubishi Tanabe Pharma America's Radicava, is just the second medicine for ALS approved in the U.S. (the other being Sanofi's Rilutek).

Speaking of Novartis — the company's experimental CTL019, which is expected to be the first approved drug in a revolutionary new cancer treatment space that turns the body's own immune cells into cancer - killers, is already facing some apprehension from doctors and patient groups who are worried about its eventual pricing.

Drug - maker Gilead Sciences was already having a stellar 2013 on the strength of its industry - leading line of HIV and AIDS drugs, but the stock really kicked into high gear after the FDA approved its latest Hepatitis C treatment, Sovaldi, in December.

The companies have begun to market their «biosimilar» (a generic version of expensive biologic drugs) of Remicade — a copycat of J&J's best - selling rheumatoid arthritis and immunology treatment (which garnered more than $ 5 billion in U.S. sales last year) and was approved by the Food and Drug Administration (FDA) in April — at a striking 35 % discount to its list price.

Though hailed as «a new therapeutic principle» in 1990, it nonetheless took another eight years for the FDA to approve the first antisense drug, fomivirsen — for the treatment of AIDS - related retinitis caused by human cytomegalovirus.

Semaglutide is expected to be approved as a diabetes treatment in December and will be launched under the brand name Ozempic, Novo said.

InterMune said Health Canada approved Esbriet as a treatment for mild - to - moderate idiopathic pulmonary fibrosis in adults.

In August 2015 the FDA approved Addyi, a once - daily, nonhormonal HSDD treatment spearheaded by Raleigh, N.C. - based Sprout Pharmaceuticals, founded in 2011 by Whitehead and her husband, Robert.

Approved treatments included gene therapies and the first new drugs for rare diseases in many years.

In March, the U.S. Food and Drug Administration (FDA) approved BLINCYTO for the treatment of adults and children with B - cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent.

«Further testing is required before Song's device could be approved as a treatment for dementia or Alzheimer's, but if it is able to help those patients regain even part of their lost memory function, the impact would be felt not only by the patients themselves, but their families and even the economy at large,» says Science Alert, which notes that Alzheimer's was responsible for a whopping $ 236 billion in healthcare costs last year.

While it's not approved specifically for anti-aging treatments, like other drugs, it can be prescribed for so - called off - label uses as long as there is no advertising or efficacy claims involved.