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Two senior FDA officials have recused themselves from involvement in agency approval decisions for coronavirus therapeutics or vaccines due to their oversight roles in the administration’s new COVID-19 research initiative. Read More
Gilead Sciences has ramped up the number of remdesivir vials it’s donating to the U.S. government to approximately 940,000 from 607,000, HHS said this week, even as the drugmaker has decided to end two trials it’s conducting on the antiviral. Read More
Rick Bright, former director of HHS’s Biomedical Advanced Research and Development Authority (BARDA), told lawmakers in a hearing yesterday that the frequently cited 12- to 18-month timeline for developing a COVID-19 vaccine is unlikely to pan out. Read More
In a Senate hearing yesterday, FDA Commissioner Stephen Hahn said there is “a lot to be learned” from mishaps during the administration’s initial distribution of remdesivir for COVID-19 patients. Read More
The European Medicines Agency (EMA) has expanded its recommendations for compassionate use of Gilead Sciences’ remdesivir for patients with severe COVID-19. Read More
HHS has not yet used its new authority under the 21st Century Cures Act to recruit more senior biomedical scientists for the FDA and other agencies, the Government Accountability Office said in a new report released Friday. Read More
Maryland Gov. Larry Hogan last week vetoed legislation that would have funded the state’s Prescription Drug Affordability Board, an independent body established last year to evaluate costly drugs and set price caps. Read More
Following widespread criticism of the federal government’s handling of COVID-19 treatment remdesivir, HHS released details on Saturday of its distribution plan of the drug, and said states will make the final call on which hospitals get the drug. Read More