Outlook Therapeutics® Submits Special Protocol Assessment (SPA) to FDA for Non-Inferiority Study of ONS-5010
19. Dezember 2023 08:05 ET
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Outlook Therapeutics, Inc.
NORSE EIGHT study on track to commence in Q1 2024Resubmission of ONS-5010 Biologics License Application (BLA) in the U.S. expected by the end of calendar year 2024 ISELIN, N.J., Dec. 19, 2023 ...
Outlook Therapeutics® Announces Strategic Organizational Realignment
06. Dezember 2023 08:05 ET
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Outlook Therapeutics, Inc.
Realignment focused on supporting ONS-5010 U.S. and EU regulatory and commercial prioritiesContinued progress toward commencement of additional adequate and well-controlled study to support the...
Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010
27. November 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
14. November 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
02. November 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
01. November 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
29. September 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
21. September 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
05. September 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
30. August 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 ...