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The FDA has approved Regeneron Pharmaceuticals’ Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn), a combination of three monoclonal antibodies, making it the agency’s first approved treatment for the Ebola virus. Read More
Fewer than a third of new drugs approved by the FDA and the European Medicines Agency over the past decade had high therapeutic value, a team of U.S. and Swiss researchers found. Read More
The FDA said the drug could lead to opioid “stacking,” as patients will need an additional opioid following treatment, increasing the risk of adverse effects. Read More
Avenue Therapeutics has a received a Complete Response Letter (CRL) from the FDA regarding its new drug application (NDA) for intravenous tramadol, meant for treating acute pain in adults. Read More
Johnson & Johnson (J&J) has reached an advance purchase deal with the European Commission to provide up to 200 million doses of its COVID-19 vaccine candidate. Read More