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Albireo’s Bylvay approved in EU and US for rare paediatric liver disease
pharmatimes
July 23, 2021
Albireo Pharma’s Bylvay has received approval on both sides of the Atlantic this week, scoring authorisation in the EU and US for the treatment of all subtypes of progressive familial intrahepatic cholestasis (PFIC).
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FDA Approves Drug for Severe Itching in Patients Liver Disease
americanpharmaceuticalreview
July 22, 2021
FDA has approved Bylvay (odevixibat), the first treatment for pruritus (moderate to severe itching) in patients aged three months and older with progressive familial intrahepatic cholestasis (PFIC), a rare progressive liver disease that typically ...
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FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC)
drugs
July 21, 2021
Albireo Pharma, Inc. today announced U.S. Food & Drug Administration (FDA) approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC).
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Albireo wins back-to-back US, EU nods for bile acid modulator Bylvay
firstwordpharma
July 21, 2021
Albireo Pharma on Tuesday said the FDA cleared Bylvay (odevixibat) to treat moderate-to-severe itching in patients aged three months and older with progressive familial intrahepatic cholestasis (PFIC), making it the first drug approved for all subtypes of
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New Phase 3 Data at WCPGHAN Show Long-Term Safety, Tolerability, and Treatment Benefits of Bylvay (odevixibat) in PFIC
firstwordpharma
June 04, 2021
Albireo Pharma, Inc. today presented clinical data from its Phase 3 PEDFIC 1 study and an interim data cut of the PEDFIC 2 long-term extension study of its lead product candidate, Bylvay (odevixibat).