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Veterans will have access to Aduhelm even though the Department of Veterans Affairs (VA), a Biogen spokesman has told FDAnews — although getting ahold of the controversial antiamyloid antibody won’t be easy. Read More
Several drugmakers have offered suggestions in written comments to the agency for revisions to the FDA’s draft guidance on in vitro testing and labeling of oral drugs intended to be given by enteral tube. Read More
The FDA is poised to authorize a booster dose of the Pfizer/BioNTech or Moderna COVID-19 vaccines for immunocompromised people as soon as today. Read More
The FDA has issued a Complete Response Letter to San Francisco biotech FibroGen for roxadustat, its investigational drug for anemia linked to chronic kidney disease (CKD), calling for an additional clinical study before the agency will consider approving the drug. Read More
Expanding its existing Solidarity trial, the World Health Organization (WHO) will test three additional anti-inflammatory drugs as potential treatments for COVID-19. Read More
Many oncologists who penned a February letter to President Biden endorsing Janet Woodcock’s nomination as permanent FDA commissioner received significant payments from drugmakers, a new analysis by researchers at Georgetown University reveals. Read More