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 ...

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.

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 ...

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

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 ...

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 ...