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 ...
"Astellas stands by the clinical profile of Izervay, the only FDA-approved GA treatment that consistently demonstrated ...
The FDA has denied Astellas’ attempt to bolster the label for its vision loss treatment Izervay with additional two-year data ...
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 ...
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.
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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 ...
In late-session trading, investors were selling out of Apellis, to the point where its price was down by nearly 6%. By ...
In August 2023, the FDA approved Izervay to treat the same patient population. Japan's Astellas Pharma (OTC: ALPMY) invested $5.9 billion to acquire the company that developed Izervay. Competing ...
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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