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Outlook Therapeutics Announces Receipt Of Type A Meeting Official Minutes On ONS-5010 BLA

Biopharmaceutical company Outlook Therapeutics, Inc. (OTLK) announced Monday the receipt of the official minutes from the Type A meeting with the U.S. Food and Drug Administration (FDA) held in October 2023. ....

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ROSEN, TRUSTED INVESTOR COUNSEL, Encourages Outlook

NEW YORK, Nov. 19, 2023 (GLOBE NEWSWIRE) WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Outlook. ....

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OTLK INVESTOR NOTICE: ROSEN, NATIONAL TRIAL LAWYERS,

NEW YORK, Nov. 16, 2023 (GLOBE NEWSWIRE) WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Outlook. ....

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Outlook says CRL for wet AMD is a surprise

After hitting the safety and efficacy endpoints in a pivotal study of wet age-related macular degeneration (AMD), Outlook Therapeutics Inc.’s CEO said he had not expected to receive a complete response letter (CRL) from the U.S. FDA. The BLA for ONS-5010 (bevacizumab-vikg) now is on hold, the company said, because the agency said chemistry, manufacturing, and controls management problems were getting in the way, along with “open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.” ....

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