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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
Mylan said it will waive its exclusive U.S. distribution rights for its copycat of AbbVie’s HIV antiviral Kaletra (lopinavir/ritonavir) to allow other suppliers to manufacture the potential COVID-19 treatment. Read More
President Trump signed a stimulus measure Friday that would help prevent drug shortages and change how the FDA deals with over-the-counter drugs. Read More