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Bayer's riociguat gives FDA new opportunity to shift how it evaluates PAH rugs
Monday, August 12, 2013
If FDA approves Bayer AG's
entire dose titration scheme for Adempas riociguat, the agency will be
departing from its past decisions on PAH drugs, which have been determined by
significant improvements on six-minute walk distance, not by surrogate
The agency's Cardiovascular and
Renal Drugs Advisory Committee laid the groundwork last week.
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