ENDPOINTS NEWS9h
FDA re­jects Astel­las’ ef­fort to sup­port longer use of eye drug Iz­er­vay
The FDA has denied Astellas’ attempt to bolster the label for its vision loss treatment Izervay with additional two-year data ...
Investing11h
Apellis Pharmaceuticals shares surge following Astellas Pharma’s FDA setback
Investing.com - Shares of biopharmaceutical firm Apellis Pharmaceuticals Inc (NASDAQ: APLS) surged 16.44% to $31 on Tuesday ...
STAT14h
A win for Apellis, a setback for Astellas
The FDA rejected an application from Astellas seeking to change the prescribing label for its eye drug Izervay to allow less ...
Astellas receives Complete Response Letter for Izervay, Apellis rallies
Astellas Pharma (ALPMY) announced the Food and Drug Administration issued a Complete Response Letter regarding the supplemental new drug ...
Astellas CRL ‘clearly a positive’ for Apellis, says JPMorgan
JPMorgan says Astellas Pharma’s (ALPMY) (ALMPY) announcement that the FDA has issued a Complete Response Letter regarding for Izervay in ...
ophthalmologytimes15h
FDA issues CRL to Astellas' Supplemental New Drug Application for avacincaptad pegol intravitreal solution (IZERVAY)
Astellas said in a press release that the FDA comments in the CRL relate to proposed labeling language, not safety.
pharmaphorum20h
FDA says no to Astellas' geographic atrophy drug
"Astellas stands by the clinical profile of Izervay, the only FDA-approved GA treatment that consistently demonstrated ...