The U.S. FDA granted Outlook Therapeutics' appeal for the retinal drug LYTENAVA following a Formal Dispute Resolution process. The company plans to resubmit its biologics license application in June 2026. If approved, LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab with FDA-approved manufacturing and labeling.
The biotech firm successfully appealed an FDA decision, with regulators now acknowledging substantial evidence of effectiveness for its retinal drug.
Read the full storyThe FDA accepted the NDA for BBP-418 to treat LGMD2I/R9 with a PDUFA target action date set for November 27, 2026.
The US FDA granted Precigen seven years of market exclusivity for PAPZIMEOS, protecting the first-of-its-kind gene therapy for adult RRP through August 2032.
The FDA accepted Nuvalent's NDA for neladalkib with Priority Review, setting a PDUFA date for November 2026 as the company hires a Chief International Officer.
The company filed for accelerated approval of z-rostudirsen following positive DELIVER trial results showing functional improvements in patients.