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Biologics
FDA approves 2 therapeutic firsts
by Shi En Kim
November 25, 2022
| A version of this story appeared in
Volume 100, Issue 42
In a span of less than a week, the US Food and Drug Administration approved two new therapies, each of which is a first-in-class treatment for its respective disease. The first to receive the nod was Provention Bio’s teplizumab, an antibody that can delay the onset of type 1 diabetes in patients 8 years and older. Days later came approval for CSL Behring’s Hemgenix, the first gene therapy for hemophilia B. The one-time treatment restores peoples’ ability to produce proteins that help with blood clot formation.
The power is now in your (nitrile gloved) hands
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