- cafead   Oct 17, 2023 at 10:32: AM
via Aldeyra Therapeutics on Monday announced in an SEC filing that the FDA is likely to reject its New Drug Application for reproxalap for the treatment of dry eye disease.
This follows a late-cycle review meeting in which the regulator flagged “substantive review issues” with the New Drug Application (NDA).
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This follows a late-cycle review meeting in which the regulator flagged “substantive review issues” with the New Drug Application (NDA).
article source