The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the supplemental new drug ...
Astellas Pharma (ALPMY) announced the Food and Drug Administration issued a Complete Response Letter regarding 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 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 ...
The agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless ...
JPMorgan says Astellas Pharma’s (ALPMY) (ALMPY) announcement that the FDA has issued a Complete Response Letter regarding for Izervay in ...
What’s an example of a well-executed drug launch? Look no further than Reata’s commercialization of Skyclarys, the first ...
The FDA rejected an application from Astellas seeking to change the prescribing label for its eye drug Izervay to allow less ...
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, a ...
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