Top Regulatory News Stories – Week Ending June 21, 2019

Blueprint Medicines announced it has submitted a NDA to the FDA for avapritinib for the treatment of adult patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of prior therapy, and fourth-line GIST.  https://www.drugs.com/nda/avapritinib_190614.html?utm_source=ddc&utm The FDA announced that generic drug applicants will now have access to more information from the agency when deciding[…]