Complement C5 inhibitor Izervay has been approved in the US since ... issues with the safety and efficacy data submitted for the label update, adding that it is "seeking clarification" on what ...

Unless Astellas is able to work with the FDA to reverse this decision in the future, every other month dosing will not be part of the Izervay label, and recommended Izervay dosing is still limited ...

Astellas Pharma (ALPMY) announced the Food and Drug Administration issued a Complete Response Letter regarding the supplemental new drug application for Izervay for the treatment of geographic ...

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the supplemental new drug application (sNDA) of Astellas Pharma’s IZERVAY (avacincaptad pegol ...

to offset competitive concerns around Izervay’s recently granted permanent J-code and likely 2H24 label expansion to include two-year data.” Citi said the "disparate commentary around share ...