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July FDA approvals deliver first products for three biotechs
Six novel drugs include first oral PCSK9 inhibitor
August 11, 2026 10:08 PM UTC
July’s FDA approvals included the first products from three biotechs.
Vera Therapeutics Inc. (NASDAQ:VERA) received accelerated approval for Trutakna atacicept to treat primary immunoglobulin A nephropathy. Celcuity Inc. (NASDAQ:CELC) plans to launch Revtorpyk gedatolisib this quarter; it licensed the mTOR and PI3K inhibitor from Pfizer Inc. (NYSE:PFE) in 2021. Outlook Therapeutics Inc. (NASDAQ:OTLK) won approval for Lytenava bevacizumab, the first ophthalmic formulation of bevacizumab approved by FDA to treat wet AMD. Compounded Avastin bevacizumab is a less expensive alternative to Lucentis ranibizumab and Eylea aflibercept, but Outlook has not yet announced pricing for Lytenava...