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There is no sign of a slowdown in letters to the FDA seeking assurances that the agency will not bend to political pressure to approve a COVID-19 vaccine ahead of the Nov. 3 presidential election. Read More
Philip Krause, deputy director of the FDA’s Office of Vaccines Research and Review, said this week that the fate of the agency’s guidance on its expectations for COVID-19 vaccine Emergency Use Authorization (EUA) remains uncertain as it goes through the White House’s review. Read More
The FDA cited Aurolife Pharma’s facility in Dayton, New Jersey for multiple violations, including lax measures to prevent contamination and other quality failures. Read More
GlaxoSmithKline (GSK) has launched a phase 2 trial in the UK of its investigational rheumatoid arthritis treatment otilimab for hospitalized COVID-19 patients. Read More
The FDA has issued two guidances to help generic drug applicants through the abbreviated new drug application (ANDA) process, including a final guidance on the preferred timing and content for changes to tentatively approved applications. Read More
The FDA has placed a partial clinical hold on Inovio Pharmaceuticals’ planned phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, calling for more information. Read More