Keeping Track: Terlipressin Falls Short Of US FDA Approval; Novel NDAs From Pfizer And Apellis; New BTDs For Sanofi, BeyondSpring
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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An advanced immunotherapy for recurrent glioblastoma and the first biosimilar version of Lucentis for age-related macular degeneration have also been submitted for review by the European Medicines Agency for potential pan-EU authorization.
Mallinckrodt’s Terlipressin Narrowly Clears US FDA Panel As Need For Liver Treatment Outweighs Safety Worries
Advisory committee votes 8-7 to recommend approval for terlipressin to treat HRS-1 but is critical of Mallinckrodt’s plan to mitigate the risk of respiratory failure.
Pfizer’s next-generation JAK1 inhibitor, abrocitinib, continues to show beneficial effects in atopic dermatitis (eczema), in the JADE COMPARE study, comparable to the positive control dupilumab and, in the case of itch, with a faster onset at the higher dose.