US FDA’s October Outlook Includes Psoriasis Blockbuster Hopeful, Ophthalmology And Orphans
User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.
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The US FDA has accepted for review the CHS-201 Lucentis biosimilar product developed by Formycon/Bioeq that is to be sold in the US by Coherus BioSciences, shortly after approving the first ranibizumab biosimilar to treat wet age-related macular degeneration.
Congenital athymia treatment Rethymic (RVT-802) is still under FDA review, with an 8 October user fee goal date, but FDA announced the regenerative medicine product had earned a rare pediatric disease priority review voucher; agency says the notice was published in error and will be withdrawn.
Samsung Bioepis’ indication that it will not launch its FDA-approved ranibizumab biosimilar, Byooviz, before June 2022 has changed what we know about the competitive landscape for Lucentis in the US.