Reshma Kewalramani, Vertex CEO

FDA lifts hold on Ver­tex's di­a­betes stem cell ther­a­py af­ter just two months un­der the mi­cro­scope

Ver­tex Phar­ma­ceu­ti­cals has re­ceived the FDA go-ahead to con­tin­ue stud­ies for its di­a­betes stem cell ther­a­py.

The treat­ment, which Ver­tex has at­tempt­ed to de­scribe as a “cure,” had been on hold at the agency since May, when reg­u­la­tors ex­pressed con­cerns about a lack of in­for­ma­tion ahead of the dose es­ca­la­tion por­tions of the study. With the hold lift­ed, Ver­tex will be­gin en­rolling pa­tients again at the high dose lev­el.

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