The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the supplemental new drug ...

Astellas said in a press release that the FDA comments in the CRL relate to proposed labeling language, not safety.

The FDA has denied Astellas’ attempt to bolster the label for its vision loss treatment Izervay with additional two-year data ...

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 ...

JPMorgan says Astellas Pharma’s (ALPMY) (ALMPY) announcement that the FDA has issued a Complete Response Letter regarding for Izervay in ...

Belite Bio's, Tinlarebant, targets eye diseases STGD1 and GA, showing promising results but with delayed phase 3 trial data.

The agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless ...

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.

What’s an example of a well-executed drug launch? Look no further than Reata’s commercialization of Skyclarys, the first ...

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 ...

Sales of Strategic Brands supporting our future growth namely PADCEV, IZERVAY, VEOZAH, VYLOY, and XOSPATA expanded to over 150 billion yen in total with a robust growth of additional 90 billion ...