ISELIN, N.J., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company ...

Outlook Therapeutics ( ($OTLK) ) has shared an update. On December 31, 2025, Outlook Therapeutics reported that the U.S. Food and Drug ...

Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for ...

Outlook Therapeutics said on Wednesday the U.S. health regulator has declined to approve its drug for a type of eye disease, ...

Outlook Therapeutics' stock fell to a new low due to FDA rejection of its Lytenava filing for wet AMD. Efficacy evidence ...

Outlook Therapeutics has received the US FDA's CRL regarding the BLA resubmission for ONS-5010/LYTENAVA to treat wet AMD.

Learn more about whether Harrow, Inc. or Ligand Pharmaceuticals Incorporated is a better investment based on AAII's A+ ...

The FDA issued a third complete response letter for ONS-5010/Lytenava, requesting confirmatory efficacy evidence for wet AMD treatment. Lytenava is an ophthalmic bevacizumab formulation, potentially ...

The FDA issued a CRL for ONS-5010, citing the need for additional confirmatory efficacy evidence despite previous trials ...

Welcome to Fierce Pharma's regulatory tracker for the first half of 2026. | In this tracker, Fierce Pharma is recording the ...

A complete response letter is a formal communication from the FDA indicating that an application cannot be approved in its present form. In the case of Outlook Therapeutics, the FDA noted that while ...

Outlook Therapeutics received notice that the Food and Drug Administration can't approve its biologics license application for a drug designed to treat macular degeneration.