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The FDA has approved the combination of Merck’s Keytruda (pembrolizumab) and Eisai’s Lenvima (lenvatinib) for the first-line treatment of adult patients with advanced renal cell carcinoma, the companies announced late Wednesday. Read More
President Biden yesterday outlined his plan to lower prescription drug prices, calling on Congress to pass legislation enabling Medicare to directly negotiate prices. Read More
The quality management system should, among other things, ensure compliance with good laboratory practice, good clinical practice, and good storage and distribution practices, the WHO says. Read More
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Several drugmakers have offered suggestions in written comments to the agency for revisions to the FDA’s draft guidance on in vitro testing and labeling of oral drugs intended to be given by enteral tube.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
The cap on attorney contingency fees is meant to ensure that “an appropriate share of the money intended for abatement of the opioid crisis is actually used for that purpose,” wrote U.S. District Judge Dan Polster. 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