Tag Archives: scores

Albireo’s rare liver disease drug Bylvay scores back-to-back approvals in U.S., Europe

With a pair of approvals on both sides of the Atlantic, liver disease-focused biotech Albireo is off and running with its new medicine Bylvay. The oral drug, the first treatment for pruritus in patients with progressive familial intrahepatic cholestasis (PFIC), scored an FDA nod Tuesday and a European approval Monday. With the FDA’s blessing, Albireo is kicking off an “immediate”… Read More »

Johnson & Johnson’s COVID vaccine scores FDA panel backing, setting up likely authorization

A month after Johnson & Johnson’s COVID-19 vaccine posted positive data in a phase 3 study, the shot is almost ready for prime time. Late Friday, a key panel unanimously endorsed the vaccine for emergency use and sent it to the agency for an official decision. An FDA authorization for the one-dose vaccine would provide a quick lift… Read More »

Allergan scores year-end FDA nod for CGRP migraine med Ubrelvy, plans early 2020 launch

The CGRP migraine prevention field already has three meds from Amgen, Eli Lilly and Teva vying for market share, and now Allergan has scored the first approval for an oral CGRP to treat migraines as they happen. Allergan’s Ubrelvy, formerly known as ubrogepant, passed FDA gatekeepers Monday, becoming the first oral CGRP drug for the acute treatment of… Read More »