fda

This past March, Canada’s department of health changed the way it handles the huge amount of data that companies submit when seeking approval for a new drug, biological treatment, or medical device — or a new use for an existing one. For the first time, Health Canada is making large chunks of this information publicly… Read more

The CAR T-cell therapy tisagenlecleucel, marketed as Kymriah, was recently approved by the FDA for adults with certain types of non-Hodgkin lymphoma. This is the second CAR T-cell therapy approved for lymphoma and the second FDA approval for this drug. Tisagenlecleucel uses the body’s own T cells to fight cancer. T cells from a person… Read more

Treatment-resistant depression affects 1 in 3 of the estimated 16.2 million adults in the U.S. who have suffered at least one major depressive episode. For them, two or more therapies have failed and the risk of suicide is much greater. It’s a grim prognosis. There are few therapies for depression that resists treatment, which is… Read more

The drug edaravone has been approved by U.S. Food and Drug Administration as an injected treatment for amyotrophic lateral sclerosis (ALS). Edaravone, marketed as Radicava by Mitsubishi Tanabe Pharma in the US, is a nootropic and neuroprotective agent that acts to scavenge free radicals, protecting against oxidative stress, which is a probable factor in ALS… Read more

Valbenazine has been approved by the U.S. Food and Drug Administration for treatment of tardive dyskinesia. The drug, marketed under the brand name Ingrezza by Neurocrine Biosciences, becomes the first medication approved for treating the condition. Tardive dyskinesia (TD) is a difficult-to-treat and often incurable form of dyskinesia, a disorder resulting in involuntary, repetitive body… Read more