The US FDA has issued a CRL for sNDA of Astellas Pharma’s IZERVAY, a treatment for geographic atrophy (GA) secondary to AMD.

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

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

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

Astellas Pharma (ALPMY) announced the Food and Drug Administration issued a Complete Response Letter regarding the supplemental new drug ...

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

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

"Astellas stands by the clinical profile of Izervay, the only FDA-approved GA treatment that consistently demonstrated ...

Oct. 31, 2024 — A research team has found that giving iron supplements to children living with human immunodeficiency virus (HIV) in sub-Saharan Africa could be an ... Kidney Transplantation ...

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 patien ...

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 ...

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