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Roche’s cancer treatment Avastin (bevacizumab) has long been employed as an off-label option for wet age-related macular degeneration (AMD) patients. | Roche’s cancer treatment Avastin has long been employed as an off-label option for wet age-related macular degeneration patients. Now the FDA has endorsed a new formulation of the VEGF inhibitor for regulated use in the U.S. Bringing it to the market is Outlook Therapeutics, which labored through three FDA rejections to finally secure a nod. It will be known commercially as Lytenava.
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Outlook Therapeutics Targets Multibillion Dollar Ophthalmology Market With New Drug After FDA Rejection -

Outlook Therapeutics announces FDA approval of Lytenava for wet AMD

FDA approves Lytenava for wet AMD

FDA Approves Branded Bevacizumab for Wet AMD

Outlook Therapeutics has notched a win in its uphill battle to commercialize an ophthalmic version of Roche’s Avastin…

Outlook Therapeutics said the agency has reversed course regarding its reformulated version of Avastin for the eye condition…

The FDA approved LYTENAVA by Outlook Therapeutics, marking the first ophthalmic bevacizumab for wet AMD in the lucrative US…

Outlook Therapeutics shares rose after the FDA accepted its resubmitted LYTENAVA BLA and set a July 2026 target action date.

Outlook Therapeutics resubmitted a biologics license application to the FDA for ONS-5010 for the treatment of neovascular…

As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators…