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: Novartis slaps $2M-plus price tag on newly approved gene therapy… »

First Mesothelioma Treatment in 15 Years Approved

May 24, 2019 — The FDA has approved the first new treatment in 15 years for an aggressive form of lung cancer. The device, the NovoTTF-100L System made by Novocure, uses electric fields to stop solid tumors from mesothelioma from dividing. Mesothelioma is a rare but aggressive cancer strongly associated with asbestos exposure. The new… Read More: First Mesothelioma Treatment in 15 Years Approved »

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

Sprycel (dasatinib) Tablets Now Approved in Combination with Chemotherapy in Certain Pediatric Patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Print this page PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel ® (dasatinib) tablets to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.1 Sprycel… Read More: Sprycel (dasatinib) Tablets Now Approved in Combination with Chemotherapy in… »