Astellas said in a press release that the FDA comments in the CRL relate to proposed labeling language, not safety.
Astellas Pharma (ALPMY) announced the Food and Drug Administration issued a Complete Response Letter regarding the supplemental new drug ...
The FDA has denied Astellas’ attempt to bolster the label for its vision loss treatment Izervay with additional two-year data ...
"Astellas stands by the clinical profile of Izervay, the only FDA-approved GA treatment that consistently demonstrated ...
The agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless ...
JPMorgan says Astellas Pharma’s (ALPMY) (ALMPY) announcement that the FDA has issued a Complete Response Letter regarding for Izervay in ...
What’s an example of a well-executed drug launch? Look no further than Reata’s commercialization of Skyclarys, the first ...
Medpage Today on MSN14d
FDA Grants Market Authorization to Light-Therapy System for Dry AMDThe FDA announced marketing authorization of a form of light therapy as the first-ever treatment for dry age-related macular ...
While Astellas’ Izervay and Apellis’ Syfovre battle for market share in geographic atrophy (GA) in the United States, both companies are struggling to reach patients in the indication in Europe.
In August 2023, the FDA approved Izervay to treat the same patient population. Analysts are encouraged by Syfovre's resilience as an eye treatment despite competition from Izervay. With more than ...
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 ...
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