Tag: regulators

EU regulators start review of China’s Sinovac vaccine

The European Union’s drug regulator announced Tuesday that it has started a rolling review of China’s Sinovac coronavirus vaccine to assess its effectiveness and safety, a first step toward possible approval for use in the 27-nation bloc. The European Medicines Agency said Tuesday that its decision to start the review is based on preliminary results

US regulators post positive review of Pfizer vaccine data

Documents released by U.S. regulators Tuesday confirmed that Pfizer’s vaccine was strongly protective against COVID-19 and appeared safe—offering the world’s first detailed look at the evidence behind the shots. The positive review from the Food and Drug Administration sets the stage for a decision allowing the vaccine’s initial use within days. FDA regulators posted their

Regulators flag second potential carcinogen in China-made heart drug

The findings have already prompted recalls in more than 50 countries, affecting several Chinese and Indian companies.  (iStock) European and North American regulators have said they are examining a second potentially cancer-causing substance in a commonly-used blood pressure drug made by Chinese firm Zhejiang Huahai Pharmaceuticals. Statements from health regulators in the EU, United States

US regulators approve the first migraine-prevention drug

New once-a-month drug offers hope to millions with severe migraines (and it will be available next week) The injected medication Aimovig is due to be available within the next week Unlike other migraine drugs, it does not cause side effects like weight gain Side effects can be worse than migraines, with up to 86% stopping