Tag Archives: Approved

Novartis slaps $2M-plus price tag on newly approved gene therapy Zolgensma—and cost watchdogs approve

Industry watchers have been speculating for months about just how high Novartis would price gene therapy Zolgensma on approval—and just how payers would cover it. And with the FDA’s green light, they now have an answer. The Swiss drugmaker will roll out the drug, a one-time treatment for pediatric patients less than 2 years of… Read More »

Neuroform Atlas Stent System FDA Approved to Treat Brain Aneurysms with Embolic Coils

May 21st, 2019 Medgadget Editors Neurology, Neurosurgery, Radiology The FDA has issued Stryker with approval for the company’s Neuroform Atlas Stent System. It is indicated for treatment of wide-neck, intracranial aneurysms in conjunction with embolic detachable coils, so far only the second stent approved for such procedures. The nitinol Neuroform Atlas stent is used to… Read More »

Fast-Acting Depression Drug, Newly Approved, Could Help Millions

Of the 16 million American adults who live with depression, as many as one-quarter gain little or no benefit from available treatments, whether drugs or talk therapy. They represent perhaps the greatest unmet need in psychiatry. On Tuesday, the Food and Drug Administration approved a prescription treatment intended to help them, a fast-acting drug derived… Read More »