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

Astellas Pharma (ALPMY) announced the Food and Drug Administration issued a Complete Response Letter regarding 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 agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless ...

"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 ...

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.

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

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

The FDA rejected an application from Astellas seeking to change the prescribing label for its eye drug Izervay to allow less ...

Astellas confirmed today that it will withdraw ... where the complement C5 inhibitor was approved by the FDA as Izervay last year for GA secondary to age-related macular degeneration (AMD ...