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 ...

Astellas Pharma (JP:4503) has released an update ... a Complete Response Letter from the FDA regarding its supplemental New Drug Application for IZERVAY, a treatment for geographic atrophy linked to ...

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.

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 ...

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

helping allow Iveric’s Izervay to have similar success upon its launch six months later. With Iveric Bio buyout, Astellas CEO Naoki Okamura acted on the company's mantra to be 'aggressive ...

There are no currently approved treatments for GA secondary to AMD outside the US, where ACP was approved under the name IZERVAY in August 2023. Astellas will work with regulatory authorities to ...