Tag Archives: Approved

Emgality Approved to Treat Episodic Cluster Headache in Adults – Neurology Advisor

The Food and Drug Administration (FDA) has approved Emgality (galcanezumab-gnlm; Lilly) for injection for the treatment of episodic cluster headache in adults. The approval was based on the results from a phase 3 double-blind, placebo-controlled trial that included 106 patients diagnosed with episodic cluster headaches. Patients were randomized to receive either once-monthly Emgality 300mg administered… Read More »

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 »

An Opioid That’s One Thousand Times More Potent Than Morphine Is Approved at Height of Opioid Addiction Crisis

An estimated 202,600 Americans died from opioid overdoses between 2002 and 2015,1 and drug overdoses are now the leading cause of death among Americans under the age of 50.2 Despite all the public warnings and national efforts to rein in this lethal trend, overdose cases admitted into emergency rooms still increased by more than 30… Read More »