Shots:
The US FDA approved six notable therapies in July 2026 across nephrology, oncology, cardiometabolic disease, ophthalmology, and neuropsychiatry, highlighting continued progress in specialty and chronic disease treatment.
Key approvals included Trutakna (atacicept) for IgA nephropathy, Revtorpyk (gedatolisib) for HR+/HER2- breast cancer, Lipfendra (enlicitide) for hypercholesterolemia, Jideytro (zidesamtinib) for ROS1-positive NSCLC, Lytenava (bevacizumab-vikg) for wet AMD, and Simtriyo (centanafadine) for ADHD, expanding treatment options across diverse patient…
Shots:
The US FDA has approved Outlook’s Lytenava (Bevacizumab-vikg) for wet AMD
Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized IgG1 MAb targeting VEGF
Additionally, the approval is expected to provide LYTENAVA with 12 years of Reference Product Exclusivity under the BPCIA
Ref: Outlook Therapeutics | Image: Outlook Therapeutics | Press Release
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The FDA issued a complete response letter for the ONS-5010/LYTENAVA™ BLA resubmission, declining approval for wet AMD in its current form
The ONS-5010 BLA resubmission was based on full NORSE trial data, including the pivotal NORSE TWO and confirmatory studies like NORSE EIGHT, a study evaluating ONS-5010 vs ranibizumab in a 12-wk trial of…
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The US FDA has accepted the resubmitted BLA of ONS-5010 (bevacizumab-vikg) for the treatment of wAMD, considering a Class 1 review & granting a PDUFA goal date Dec 31, 2025; if approved, it will be branded Lytenava
ONS-5010 (intravitreal) is an ophthalmic bevacizumab formulation that binds all VEGF isoforms to block VEGF interaction with…
Shots:
Outlook’s Lytenava has received CHMP’s positive opinion to treat Wet AMD. If approved Lytenava expected to gain 10 yrs of market exclusivity in EU
The opinion was supported by 3 wet AMD clinical programs (NORSE ONE, NORSE TWO & NORSE THREE) assessing ONS-5010 along with retrospective bibliographic literature
Lytenava, an ophthalmic formulation of bevacizumab,…

