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

Cases of several dangerous bacterial infections and viruses have been growing around the U.S. CBS News medical contributor Dr ...

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 ...

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

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

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

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 ...

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 ...

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 ...