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The European Commission has inked a supply deal with Gilead Sciences for 500,000 courses of the company’s antiviral drug remdesivir to shore up Europe’s depleting stocks of the COVID-19 treatment. Read More
The Government Accountability Office (GAO) wants the FDA to institute several changes to its three-year-old Office of Laboratory Safety (OLS), which was formed to improve safety in the agency’s labs that work with hazardous biological agents. Read More
Arbor Pharmaceuticals’ AR19, an abuse-deterrent formulation of amphetamine sulfate for attention deficit hyperactivity disorder (ADHD) should not receive FDA approval, two of the agency’s advisory committees voted unanimously in a joint meeting yesterday. Read More
In a move to show it’s a good corporate citizen during the pandemic, Moderna has vowed not to wield its COVID-19 related patents against other coronavirus vaccine manufacturers as the crisis continues. Read More
Regeneron Pharmaceuticals submitted a request for Emergency Use Authorization (EUA) for its COVID-19 antibody treatment Thursday, just one day after Eli Lilly filed for authorization of its own monoclonal antibody. Read More
The expert panels are weighing the drug’s risks and benefits, including potential public health impacts and whether the evidence supports abuse-deterrent labeling. Read More
The editors of the New England Journal of Medicine have broken with the medical journal’s long tradition of avoiding political issues and published a scathing criticism of the government’s management of the COVID-19 crisis, claiming that the FDA has been “shamefully politicized.” Read More
The biosimilars market has had a plodding start in the U.S., but the products are finally picking up momentum, IQVIA reported, citing three examples of new products with strong potential. Read More
Dozens of medical experts from across the nation have written a letter to FDA Commissioner Stephen Hahn, Center for Biologics Evaluation and Research (CBER) Director Peter Marks and the FDA’s vaccine advisory committee calling for stronger requirements for monitoring participants in COVID-19 vaccine trials. Read More