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 Uses Real-World Data to Approve Boostrix for Prevention of Infection in Infants
October 8th 2022Regulators used a re-analysis of data from an observational case-control study of Tdap vaccine effectiveness to show that Boostrix given in the third-trimester prevented pertussis among infants.
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FDA Advisory Committee Votes Against Copiktra in CLL/SLL
September 26th 2022Committee members felt the data on overall survival for patients treated with Copiktra was difficult to interpret, and the therapy was associated with a higher risk of serious side effects and deaths compared with Kesimpta.
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