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 ...

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 ...

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

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

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

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

The attack came just days after President Biden gave Ukraine permission to use the weapons to strike targets inside Russia. By Marc Santora and Eric Schmitt The envoy, Amos Hochstein, said an ...

Footage of a man being shoved into a wall by a police officer before being dragged through a front yard has been shared on social media, with SA Police confirming a formal complaint has been made ...

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