Blueprint Lays Out Path To Early Approval In Small GIST Population
Blueprint Medicines will pursue an accelerated path to approval for its newly designated breakthrough therapy BLU-285 in the treatment of gastrointestinal stromal tumors in a small subset of patients.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Kinome-focused Blueprint Medicines plans to follow up its first NDA, for all lines of therapy in patients with exon 18 mutant GIST or fourth-line use in non-genomically selected patients, with submissions for third-line GIST and advanced systemic mastocytosis in 2020.
First quarter VC investments in biopharma set high expectations for the second quarter; Acorda cuts jobs after patent litigation defeat, plus other strategic realignments; no new US IPOs, but Europe has three; and notable follow-on offerings.