April 22nd 2024
Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
April 11th 2024
FDA Advisory Committee Supports COVID-19 Boosters for Some People
September 18th 2021The vaccines advisory committee voted late on Friday, September 17, 2021, to provide emergency authorization of Pfizer’s COVID-19 vaccine as a booster for those over the age of 65, as well as for those at high risk of developing severe disease.
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FDA’s New Warning Includes Xeljanz and other JAK Inhibitors
September 3rd 2021The FDA’s review of the JAK inhibitor class concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with these arthritis and ulcerative colitis medicines.
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Keytruda Receives Full Approval as First-Line Treatment in Bladder Cancer
September 1st 2021The approval follows the FDA’s Oncologic Drugs Advisory Committee voting 5-3 in favor of maintaining the approval despite a confirmatory trial that found Keytruda did not meet the end points of overall survival and progression-free survival.
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