FDA, Covid-19
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1st Blood Test to Diagnose Alzheimer’s Cleared by FDA
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The supply of GLP-1 drugs for weight loss and diabetes treatment is expected to tighten this week with a federal deadline to halt the sale and production of off-brand products that many patients in the United States have come to rely on.
Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are healthy
"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk," the agency said in an article published by The New England Journal of Medicine, authored by FDA Commissioner Dr. Martin Makary and his new top vaccines official, Dr. Vinay Prasad.
FDA FLAGS SEVERE ITCH — Patients who stop using the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) may experience rare but severe itching after longtime use, the FDA has cautioned.
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The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65, effectively limiting their availability later this year to older adults and those at risk of developing severe illness,
A cucumber recall has been linked to a salmonella outbreak in multiple states and is under investigation by the U.S. Food and Drug Administration, the agency announced Monday. A May 19 news release from the FDA reports that 26 people across 15 states have become ill in the outbreak of salmonella montevideo.
Johnson & Johnson has won the support of an FDA expert panel in its bid to make Darzalex the first treatment for an early form of multiple myeloma despite uncertainties raised by regulators.
Moderna filed for FDA approval of its mRNA-1083 combination shot last year. The submission put the biotech on track to win approval in adults aged 50 and older in November 2025. However, at the start of May, Moderna pushed back the expected approval date to 2026 after the FDA asked to see phase 3 efficacy before making a decision on authorization.