Shortly after rolling out interim data on its COVID-19 antibody hopeful, Eli Lilly last week sent the therapy ahead to the FDA for a potential emergency nod. If the antibody crosses the finish line, Lilly can expect a huge surge in demand—and it’s bringing in a manufacturing partner to help out. Lilly has signed on… Read More »
August 23, 2020 — Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may… Read More »
Days after U.S. officials and others reported the first positive controlled data for Gilead’s remdesivir in COVID-19, the FDA has given the drug an emergency use authorization. President Donald Trump and Gilead CEO Daniel O’Day made the announcement Friday afternoon at the White House, according to CNBC’s Meg Tirrell. An FDA fact sheet on the… Read More »
The World Health Organization today declared the coronavirus a Public Health Emergency of International Concern. In the U.S., the Centers for Disease Control and Prevention today confirmed its first case of the spread of the coronavirus by person-to-person contact, bringing the total number of cases in this country to six. In all of the other… Read More »