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Manufacturers need to provide two-week updates on any supply issues during the COVID-19 emergency and going forward, the FDA said in a new straight-to-final guidance. Read More
The FDA has updated its guidance on conducting clinical trials during the COVID-19 pandemic with an extensive Q&A section, including a long list of factors to consider when deciding the status of ongoing trials and ones soon to be initiated. Read More
The FDA issued an emergency use authorization (EUA) for the anti-malaria drugs hydroxychloroquine sulfate and chloroquine phosphate, clearing the way for HHS to distribute millions of doses for COVID-19 patients. Read More
In another blow to Genentech’s blockbuster cancer drug Herceptin, a federal appeals court upheld the U.S. Patent Trial and Appeals Board’s invalidation of two patents it holds on the drug. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended AveXis’ spinal muscular atrophy gene therapy Zolgensma along with seven other medicines at its March meeting. Read More