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The new ALS product is a fixed-dose combo of two ingredients – sodium phenylbutyrate and taurursodiol – that some patients currently are compounding. Amylyx says it will explore ‘all options’ in addressing that, noting its strong IP for Relyvrio, but also committing to access.
Keeping Track: US FDA Clears Santen’s Omlonti, Fennec’s Pedmark; Lilly’s Retevmo Adds Tumor-Agnostic Claim
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker
Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals
New data from anemic myelofibrosis patients showed the drug reduced transfusion dependence, which that could unlock a more sizeable portion of the market for CTI BioPharma.
- Medical Devices
- Other Names / Subsidiaries
- Clarient Inc.
- Asymptote Limited
- GE Healthcare
- GE Medical Systems LLC
- Monica Healthcare
- Novia Strategies
- Vital Signs.
- Zionexa SAS