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August 30, 2023 06:00 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Provides Regulatory Update on FDA Review of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

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 ...
August 14, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2023 and Reiterates Key Anticipated Near-Term Milestones

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...
August 01, 2023 08:45 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2023

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...
May 15, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Reports Financial Results for Second Quarter Fiscal Year 2023 and Provides Corporate Update

Upcoming 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...
April 27, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® to Present at the H.C. Wainwright BioConnect Investor Conference

ISELIN, N.J., April 27, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of...
March 13, 2023 07:00 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Confirms It Has No Exposure to Silicon Valley Bank

ISELIN, N.J., March 13, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of...
February 14, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2023 and Provides Corporate Update

Pre-launch commercial activities underway as Company advances toward U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023 for ONS-5010 /...
February 07, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® to Present at the SVB Securities Global Biopharma Conference

ISELIN, N.J., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of...
January 19, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® Strengthens Medical Affairs and Commercial Expertise with Appointments of Surendra Sharma, MD, Senior Vice President of Medical Affairs and Glen Olsheim, Executive Director of Commercial Excellence

ISELIN, N.J., Jan. 19, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of...
January 09, 2023 08:05 ET | Source: Outlook Therapeutics, Inc.

Outlook Therapeutics® to Present at the Virtual Investor 2023 Companies to Watch Event

ISELIN, N.J., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of...