Tag Archive for: momelotinib

The company said that the marketing authorization decision could come early next year.

Following a regulatory victory for Jemperli in endometrial cancer last month, GSK continues its oncology winning streak with an FDA approval for momelotinib in myelofibrosis with anemia.

This week, GSK is expecting a verdict for its myelofibrosis candidate momelotinib and Alnylam will make the case for patisiran in cardiomyopathy of ATTR amyloidosis.

GSK Plc said on Friday the U.S. Food and Drug Administration (FDA) has extended the review period by three months for a drug the British drugmaker gained through its $1.9 billion buyout of Sierra Oncology last year.

GSK has dropped both GSK3915393, an investigational celiac disease therapeutic, and GSK3878858, a Staphylococcus aureus vaccine hopeful, from its clinical development roster, the company revealed Wednesday.