We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
If the drug is meant to slow or arrest disease progression but not reverse it, the trial should last long enough to observe disease progression in the control group, the agency says. Read More
Health Canada released new guidelines on Friday to help prescription drug companies comply with the agency’s plain language labeling requirements. Read More
Health Canada has finalized regulations that knock the U.S. and Switzerland off its price comparator list and tighten disclosure requirements. Read More
A group of senators hit out at Novartis subsidiary AveXis on Friday for using falsified data in the approval process of its gene therapy product Zolgensma (onasemnogene abeparvovec-xioi). Read More
The agency will not award any vouchers after Sept. 30, 2020, unless the application is for a drug that was designated as a drug for a rare pediatric disease. Read More