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.
Blueprint Medicines Corp.’s recent submission of its first new drug application for its lead candidate avapritinib could be followed by four more filings in the next 18 months, chief executive officer Jeffrey Albers told a 17 June 2019 conference call. Three of those planned filings include an indication with a breakthrough therapy designation.
The NDA for avapritinib, a highly selective KIT and platelet-derived growth factor receptor alpha (PDGFRA) inhibitor, seeks approval in two...
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
