Progenics
Pharmaceuticals of Tarrytown, N.Y., announces that the Food
and Drug Administration has granted fast-track status
to its PRO 140 therapeutic for the treatment of HIV.
The drug, which is now in early-stage trials, is a
humanized monoclonal antibody directed against CCR5, a
molecular portal that HIV uses to enter cells. Fast-track
status streamlines the regulatory review process. The
drug may also be considered for priority six-month
review--instead of the standard 10-month review--and
accelerated approval. (AP)
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