The US FDA has issued a CRL for sNDA of Astellas Pharma’s IZERVAY, a treatment for geographic atrophy (GA) secondary to AMD.

JPMorgan says Astellas Pharma’s (ALPMY) (ALMPY) announcement that the FDA has issued a Complete Response Letter regarding for Izervay in ...

Astellas Pharma (ALPMY) announced the Food and Drug Administration issued a Complete Response Letter regarding the supplemental new drug ...

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

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

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

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

Astellas is to work with UK biotech Adaptimmune Therapeutics to develop allogeneic ‘off-the-shelf’ T-cell therapies for cancer. The Japanese pharma said its wholly-owned subsidiary Universal ...

Astellas Pharma (JP:4503) has released an update. Astellas Pharma has received FDA approval for VYLOY, a novel treatment targeting CLDN18.2 for advanced gastric and gastroesophageal junction ...

Astellas Pharma Inc. (OTCMKTS:ALPMY – Get Free Report) saw a large decrease in short interest in the month of October. As of October 31st, there was short interest totalling 9,100 shares ...

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