After successive CRLs in 2020 and 2021, the drug gained a broad label for hearing loss in children treated with cisplatin for localized, non-metastatic solid tumors.

Real-world cases of retinal vasculitis linked with Syfovre for geographic atrophy in age-related macular degeneration may have resulted from a material used in a specific filter needle, the US firm revealed, as analysts remained optimistic on the product.

Geron’s highly anticipated telomerase inhibitor has been given a user fee date by the US Food and Drug Administration next year and will also be subject to an advisory committee meeting, despite largely positive analyst sentiment on clinical results to date.