Tag Archives: approvals

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 »

Bristol Myers, flush with pair of CAR-T approvals, blueprints first cell therapy factory in Europe

Right on the heels of not one, but two CAR-T approvals in the U.S., Bristol Myers Squibb is bolstering its commercial cell therapy ambitions on the other side of the Atlantic. The company on Thursday pegged Leiden, Netherlands, as the home of its first cell therapy factory in Europe and its fifth worldwide. With planning for site design and… Read More »