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 ...

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

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 ...

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

Aclaris Therapeutics has secured an exclusive licence from Biosion for the global rights to two new antibodies, BSI-045B and ...

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

Gold prices climbed for a second consecutive session on Tuesday, hitting a one-week high as mounting Russia-Ukraine tensions ...

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