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- Sarepta receives FDA decision deadline for exon-skipping therapies, appoints Anna Protopapas as Flare CEOThe U.S. Food and Drug Administration has set a deadline for a decision on Sarepta Therapeutics' exon‑skipping drug program, with the agency expected to rule by the end of February. The timing is…
- Unicycive Therapeutics receives second FDA complete response letter for kidney drug amid manufacturing problemsUnicycive Therapeutics' chronic kidney disease drug, a phosphate binder called oxylanthanum carbonate (OLC), has been rejected by the U.S. Food and Drug Administration for a second time. The FDA c…