Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010
November 27, 2023 08:05 ET
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Outlook Therapeutics, Inc.
Resubmission of the ONS-5010 BLA on track for the end of calendar year 2024, pending final agreement on a clinical trial protocol with the FDA and successful completion of the required additional...
Outlook Therapeutics® Adds Global Commercial Expertise with Appointment of Jedd Comiskey as Senior VP - Head of Europe
November 14, 2023 08:05 ET
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Outlook Therapeutics, Inc.
ISELIN, N.J., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...
Outlook Therapeutics® Provides Update on Type A Meetings with FDA
November 02, 2023 08:05 ET
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Outlook Therapeutics, Inc.
ISELIN, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...
Outlook Therapeutics® to Present at Guggenheim’s 5th Annual Inflammation, Neurology & Immunology (INI) Conference
November 01, 2023 08:05 ET
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Outlook Therapeutics, Inc.
ISELIN, N.J., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...
Outlook Therapeutics® Requests Type A Meeting With FDA
September 29, 2023 08:05 ET
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Outlook Therapeutics, Inc.
ISELIN, N.J., Sept. 29, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...
Outlook Therapeutics® to Present at the 2023 Cantor Fitzgerald Global Healthcare Conference
September 21, 2023 08:05 ET
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Outlook Therapeutics, Inc.
ISELIN, N.J., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...
Outlook Therapeutics® to Present at the H.C. Wainwright 25th Annual Global Investment Conference
September 05, 2023 08:05 ET
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Outlook Therapeutics, Inc.
ISELIN, N.J., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...
Outlook Therapeutics® Provides Regulatory Update on FDA Review of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD
August 30, 2023 06:00 ET
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Outlook Therapeutics, Inc.
FDA issues Complete Response Letter (CRL) for ONS-5010 BLA based on CMC and need for further confirmatory clinical evidence Outlook Therapeutics working with FDA to address the Agency’s issues ...
Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones
August 14, 2023 08:05 ET
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Outlook Therapeutics, Inc.
Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010, an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration...
Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2023
August 01, 2023 08:45 ET
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Outlook Therapeutics, Inc.
ISELIN, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of...