Outlook Therapeutics, Inc.
https://outlooktherapeutics.com
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Please contact Sales at: (212) 520-2765 or email [email protected]
Latest From Outlook Therapeutics, Inc.
Outlook’s Ophthalmic Bevacizumab Knocked Back By FDA
Outlook Therapeutics has received a CRL from the US FDA over its application for an ophthalmic formulation of bevacizumab. The company says it is working with the agency to address the various issues raised.
Outlook Aims To Reverse US FDA’s Rejection Of Bevacizumab For AMD
Outlook Therapeutics received a complete response letter citing manufacturing issues and seeking more data for Lytenava (ONS-5010), its bevacizumab injection for wet age-related macular degeneration.
Complete Response Letter For Outlook’s Bevacizumab Is Both Straightforward And Elusive
Paralleling the challenges of the wet AMD market it hopes to enter, the CRL for Lytenava cites manufacturing issues, which Outlook Therapeutics feels it can easily address, as well as the need for confirmatory clinical evidence, which has left the firm scrambling for a meeting with FDA.
Henlius Announces Positive Phase I/II Results For Ophthalmic Bevacizumab Biosimilar
Henlius has successfully established the safety and preliminary efficacy of its ophthalmology-indicated bevacizumab biosimilar HLX04-O in Phase I/II trials.
Company Information
- Industry
- Biotechnology
- Pharmaceuticals
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Biotechnology
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Large Molecule
- Antibodies
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Large Molecule
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- Oncobiologics, Inc.
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