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.

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 ...

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.

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

Investing.com - Shares of biopharmaceutical firm Apellis Pharmaceuticals Inc (NASDAQ: APLS) surged 16.44% to $31 on Tuesday ...

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

I'm Naoki Okamura from Astellas Pharma Inc. Thank you very much ... Sales of Strategic Brands supporting our future growth namely PADCEV, IZERVAY, VEOZAH, VYLOY, and XOSPATA expanded to over ...

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 ...

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 ...