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You are here: Industry Insights > HRS-1

News List

US FDA denies approval to Mallinckrodt for Terlipressin to treat Hepatorenal Syndrome Type 1 expresspharma
September 16, 2020
The Complete Response Letter stated that, based on the available data, the agency cannot approve the terlipressin NDA in its current form and requires more information to support a positive risk-benefit profile for terlipressin for patients with HRS-1.
US committee backs terlipressin approval for HRS-1 pharmatimes
July 17, 2020
A US FDA advisory committee has voted in favour of approving Dublin, Ireland-based biopharma Mallinckrodt's terlipressin for Hepatorenal Syndrome Type 1 (HRS-1).

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