E Point Perfect – Interesting and beneficial content
Law \ Legal

Outlook Therapeutics Re-Submits Its Ophthalmic Bevacizumab BLA


On August 30, 2022, Outlook Therapeutics, Inc. announced that it has re-submitted its Biologics License Application (BLA) to the FDA for ONS-5010, “an investigational ophthalmic therapy which, if approved, will be branded as LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).”   As we previously reported, Outlook Therapeutics had announced in May 2022 that the FDA requested additional information in order to complete the filing of the company’s BLA for LYTENAVA.   Russell Trenary, President and CEO of Outlook Therapeutics, commented, “We remain committed to bringing ophthalmic bevacizumab to market, which if approved, can provide retina patients with an on-label treatment option that helps patients avoid the health risks associated with unapproved repackaged oncologic IV bevacizumab.”

The post Outlook Therapeutics Re-Submits Its Ophthalmic Bevacizumab BLA appeared first on Big Molecule Watch.


Source link

Related posts

EBA consultation on the amending ITS on supervisory reporting to introduce new IRRBB reporting

How Long is K-1 Visa Valid?

Moving to the U.S.? Have You Planned for the Estate and Gift Taxes?

PTAB Issues Final Written Decisions Finding Claims of Regeneron’s Aflibercept Patents Invalid

Data Transfers from European Companies to Their Non-European Affiliates

PCAOB Secures Complete Access to Inspect and Investigate Chinese Audit Firms, but SEC Signals Must Remain Vigilant