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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).
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 ...
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).
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).
CANbridge signs license agreement with Mirum for maralixibat in Greater China pharmaceutical-business-review
May 07, 2021
Biopharmaceutical company CANbridge Pharmaceuticals has signed a licensing agreement with Mirum Pharmaceuticals for the development and commercialisation of maralixibat in Greater China.
Albireo submits rare liver disease med odevixibat to FDA and EMA pharmatimes
December 14, 2020
Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC).
Mirum Initiates Maralixibat Phase 3 Clinical Trial americanpharmaceuticalreview
July 10, 2019
Mirum Pharmaceuticals announced the dosing of the first patient in the Phase 3 MARCH-PFIC clinical trial of its lead drug candidate, maralixibat, in pediatric patients with progressive familial intrahepatic cholestasis (PFIC).
Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics pharmafocusasia
March 21, 2019
Vivet Therapeutics, a privately held gene therapy biotech company dedicated to developing gene therapy treatments for inherited liver disorders with high unmet medical need, and Pfizer Inc.