Outlook Therapeutics faces a pivotal FDA decision for Lytenava on December 31st, following two prior rejections. Read why ...
Shares in biopharmaceutical group Outlook Therapeutics ($OTLK) collapsed in pre-market trading after the U.S. Food and Drug ...
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FDA issues new setback for Outlook Therapeutics’ LYTENAVA
Outlook Therapeutics ( ($OTLK) ) has shared an update. On December 31, 2025, Outlook Therapeutics reported that the U.S. Food and Drug ...
ISELIN, N.J., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company ...
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Outlook Therapeutics receives FDA response on ONS-5010 for wet AMD
Outlook Therapeutics has received the US FDA's CRL regarding the BLA resubmission for ONS-5010/LYTENAVA to treat wet AMD.
Outlook Therapeutics' stock fell to a new low due to FDA rejection of its Lytenava filing for wet AMD. Efficacy evidence ...
The FDA issued a CRL for ONS-5010, citing the need for additional confirmatory efficacy evidence despite previous trials ...
Outlook Therapeutics said on Wednesday the U.S. health regulator has declined to approve its drug for a type of eye disease, ...
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 ...
In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab ...
U.S. futures are trading higher with Nasdaq 100 Futures futures up as much as 1.1% in pre-market Friday. ASML (NASDAQ:ASML) are up 4.9% after Aletheia Capital double-upgraded the European-listed ...
CRANBURY, N.J., March 05, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ...
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