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FDA Accepts Outlook Therapeutics’ BLA for Ophthalmic Bevacizumab

Outlook Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for ONS-5010 / LYTENAVA (bevacizumab-vikg), an investigational...more

Sandoz submits BLA for proposed biosimilar trastuzumab to the FDA

Last week, Sandoz announced that it submitted a Biologic License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) to the FDA. According to the press release, the biosimilar trastuzumab was...more

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