FDA, Aldeyra

ALDX Up as FDA Accepts Resubmitted NDA for Eye Drug Reproxalap
ALDX announced that the FDA has accepted its resubmitted new drug application (NDA) for reproxalap, a first-in-class investigational RASP modulator, for the treatment of the signs and symptoms of dry eye disease.
Aldeyra announces FDA acceptance of resubmitted reproxalap application
Aldeyra Therapeutics (NASDAQ:ALDX) announced FDA acceptance of its resubmitted market application for topical ocular reproxalap for the treatment of dry eye disease and an expansion of its option agreement with AbbVie (NYSE:ABBV).
Aldeyra Therapeutics Shares Up, FDA to Review New Drug Application
Shares of Aldeyra Therapeutics gained after the Food and Drug Administration accepted the company's resubmitted new drug application for its treatment of dry eye disease for review. The stock rose 11% to $4.67 in afternoon trading Monday. Shares, despite falling 12% in the last three months, are up 35% this year.
Aldeyra says FDA accepts reproxalap NDA, AbbVie deal expanded to $100M
Aldeyra Therapeutics (ALDX) announced that the U.S. Food and Drug Administration or FDA has accepted for review the resubmitted New Drug Application NDA for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment ...
Aldeyra's FDA Resubmission And AbbVie Option Revitalize Reproxalap's Prospects
Aldeyra received an FDA CRL for reproxalap, necessitating an additional study for DED approval. Read why I continue to rate ALDX stock a buy.
bovnews4h
What’s Driving Aldeyra Therapeutics Inc (ALDX) Stock’s -17.54% Plunge Over the Past Month?
On Monday, Aldeyra Therapeutics Inc (ALDX) stock saw a modest uptick, ending the day at $4.7 which represents a slight increase of $0.49 or 11.64% from the prior close of $4.21. The stock opened at $4 ...
Business Insider1d
Aldeyra Therapeutics Says FDA Accepts NDA For Reproxalap In Dry Eye Disease
(RTTNews) - Aldeyra Therapeutics, Inc. (ALDX) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular ...
pharmaphorum4d
Aldeyra spies FDA filing ahead for dry eye drug reproxalap
Aldeyra Therapeutics' dogged persistence with its drug eye disease therapy reproxalap – despite mixed results in a phase 3 trial – may be paying off. The Massachusetts-based biotech said a ...
Managed Healthcare Executive2d
FDA Sets Review Date for Resubmitted Reproxalap in Dry Eye Disease
Developed by Aldeyra Therapeutics, reproxalap is a therapy to treat patients with the signs and symptoms of dry eye disease ...
Nasdaq5d
Aldeyra Therapeutics to Participate in the Jefferies London Healthcare Conference
Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated and metabolic diseases. Our approach is to develop pharmaceuticals ...
Morningstar19d
Aldeyra Therapeutics Selected to Present at the Disruptive Innovations Symposium during the OSN New York Retina 2024 Meeting
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases ...