As March approaches, the FDA is expected to announce key decisions on the New Drug Applications for Reproxalap, Linerixibat, Kresladi, and LNTH-2501. For Kresladi, this marks a second bid for approval, while Reproxalap is making its third attempt. The path to FDA approval is often challenging for many drug candidates.
Meanwhile, approved therapies Sotyktu and Imcivree await decisions on label expansions, adding further regulatory catalysts to the month.
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