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October 23, 2023
Positive opinion from Committee for Medicinal Products for Human Use recommending approval of Bylvay® (odevixibat) based on Phase III ASSERT clinical-trial data in Alagille syndrome (ALGS) already received in July 2023Committee for Orphan Medicinal Products confirms a negative opinion of its review recommending not to maintain the orphan designation for Bylvay in ALGSIpsen plans to submit a new Marketing Authorisation Application for the treatment of ALGS by the end of 2023 under a new bran...
October 23, 2023
Investegate announcements from Ipsen updates on E.U. Marketing Authorisation Application for odevixibat in Alagille syndrome
July 21, 2023
Positive opinion from Committee for Medicinal Products for Human Use based on Bylvay Phase III ASSERT clinical-trial data in Alagille syndrome Negative opinion from Committee for Orphan Medicinal...
July 21, 2023
Positive opinion from Committee for Medicinal Products for Human Use based on Bylvay Phase III ASSERT clinical-trial data in Alagille syndrome Negative opinion from Committee for Orphan Medicinal...
June 13, 2023
Approval heralds the second rare cholestatic liver disease indication for Bylvay in the U.S. after progressive familial intrahepatic cholestasis related pruritus in 2021 Immediate U.S. commercial... | June 13, 2023
January 17, 2023
Patients treated with the investigational combination of trifluridine/tipiracil in combination with bevacizumab in the pivotal Phase 3 SUNLIGHT trial achieved clinically meaningful improvement in
November 30, 2022
BOSTON, Nov. 30, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced
November 7, 2022
Early, rapid, and sustained efficacy across wide range of patients with evidence of disease modificationLong-term preservation of native liver in PFIC, improvements in pruritus, bile acids, and... | November 7, 2022
October 13, 2022
– New data presented at the North American Society for Pediatric Gastroenterology, Hepatology & Nutrition meeting – Earlier treatment with Bylvay provided greater efficacy in... | October 13, 2022
October 11, 2022
Highly statistically significant improvement in pruritus primary endpoint (p=0.002)Significant reductions in key secondary endpoint of serum bile acid levels (p=0.001)Substantial improvements in multiple