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13.11.25 - 14:33
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Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD (GlobeNewswire EN)
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ISELIN, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD). The FDA has advised that it considers the BLA resubmission a complete, Class 1 response to the August 27, 2025 action letter, which results in a 60 day review period from the date of resubmission. As a result, the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025. ONS-5010, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet AMD....
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03.11.25 - 14:39
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Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010 (GlobeNewswire EN)
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ISELIN, N.J., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, after receiving the official minutes from the FDA Type A meeting conducted in September 2025. ONS-5010 is an investigational ophthalmic formulation of bevacizumab which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD)....
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29.09.25 - 14:48
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Outlook Therapeutics Provides Update on Type A Meeting with FDA (GlobeNewswire EN)
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ISELIN, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has completed the Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. Based on the discussion with the FDA, Outlook Therapeutics expects to resubmit its BLA before the end of calendar year 2025, after reviewing the agency's feedback and meeting minutes....
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03.09.25 - 14:39
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Outlook Therapeutics to Present at the 2025 EURETINA Innovation Spotlight (EIS) (GlobeNewswire EN)
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ISELIN, N.J., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it will present at the EURETINA Innovation Spotlight being held as part of the 25th EURETINA Congress on September 3, 2025 in Le Palais des Congrès, Paris....
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02.09.25 - 14:39
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Outlook Therapeutics Requests Type A Meeting with FDA (GlobeNewswire EN)
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ISELIN, N.J., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD....
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10.06.25 - 14:09
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Outlook Therapeutics® Announces SMC Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD (GlobeNewswire EN)
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ISELIN, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced the Scottish Medicines Consortium (SMC) acceptance of LYTENAVA™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet age-related macular degeneration (wet AMD). LYTENAVA™ (bevacizumab gamma) is the first and only licensed ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the United Kingdom (UK) and has an initial 10 years of market exclusivity from the date of initial marketing authorization from the Medicines and Healthcare products Regulatory Agency....
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