Pharmaceutical Technology10m
FDA issues CRL to Astellas’ IZERVAY sNDA for geographic atrophy
The US FDA has issued a CRL for sNDA of Astellas Pharma’s IZERVAY, a treatment for geographic atrophy (GA) secondary to AMD.
ophthalmologytimes18h
FDA issues CRL to Astellas' Supplemental New Drug Application for avacincaptad pegol intravitreal solution (IZERVAY)
Astellas said in a press release that the FDA comments in the CRL relate to proposed labeling language, not safety.
pharmaphorum23h
FDA says no to Astellas' geographic atrophy drug
"Astellas stands by the clinical profile of Izervay, the only FDA-approved GA treatment that consistently demonstrated ...
Astellas receives Complete Response Letter for Izervay, Apellis rallies
Astellas Pharma (ALPMY) announced the Food and Drug Administration issued a Complete Response Letter regarding the supplemental new drug ...
ENDPOINTS NEWS12h
FDA re­jects Astel­las’ ef­fort to sup­port longer use of eye drug Iz­er­vay
The FDA has denied Astellas’ attempt to bolster the label for its vision loss treatment Izervay with additional two-year data ...
Astellas CRL ‘clearly a positive’ for Apellis, says JPMorgan
JPMorgan says Astellas Pharma’s (ALPMY) (ALMPY) announcement that the FDA has issued a Complete Response Letter regarding for Izervay in ...
BioPharma Dive15h
Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer
The agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless ...
4DMT Reports Third Quarter 2024 Financial Results, Operational Highlights and Expected Upcoming Milestones
Presented positive interim data for 4D-150 in wet age-related macular degeneration (wet AMD) from PRISM Phase 1/2 clinical trial highlighting robust and durable clinical activity across diverse ...
4D Molecular Therapeutics, Inc.: 4DMT Reports Third Quarter 2024 Financial Results, Operational Highlights and Expected Upcoming Milestones
Presented positive interim data for 4D-150 in wet age-related macular degeneration (wet AMD) from PRISM Phase 1/2 clinical trial highlighting robust and durable clinical activity across diverse patien ...