TAGRISSO granted FDA priority review in early-stage EGFR-mutated lung cancer
While up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease and
Harbour BioMed’s partner Solstice Oncology has raised $225m in funding to advance its lead candidate, porustobart, a neoadjuvant immuno-oncology therapy.
Xeris’ XP-0863 was previously granted orphan designations both for the treatment of acute repetitive seizures and for the treatment of Dravet Syndrome. The FDA’s Fast Track designation highlights
PMM is a complex mitochondrial disease in which genetic mutations mainly impair the function of mitochondria that may result in reduced muscle function, reduced endurance to exercise, increased
UCD is a rare and life-threatening condition caused by an inherited inborn error of metabolism. Current treatment options are associated with poor outcomes. “The rare pediatric disease designation
Venclexta was previously granted provisional approval in this setting under the FDA’s accelerated approval program in November 2018. Today’s FDA approval converts Venclexta’s accelerated approval in this setting