The Food and Drug Administration (FDA) has expanded the labeling for Izervay™ (avacincaptad pegol intravitreal solution) to include longer-term ...

In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med ...

Marci English, head of biopharma and ophthalmology development at Astellas Pharma, said the FDA's change of heart will ...

The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic ...

The US Food and Drug Administration (FDA) approved expanding the prescribing information for Japanese drugmaker Astellas ...

Izervay (avacincaptad pegol) is a prescription injection used to treat severe age-related macular degeneration (AMD). Izervay can cause side effects that range from mild to serious. Examples ...

Navigating regulatory hurdles in the U.S. and Europe, plus fierce competition from rival Apellis, Astellas’ geographic atrophy (GA) med Izervay has taken a few beatings in recent months.

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 ...

US FDA approves expanded label for Astellas’ Izervay for the treatment of geographic atrophy: Tokyo Friday, February 14, 2025, 09:00 Hrs [IST] Astellas Pharma Inc., a global lif ...

Astellas has suffered another major setback with geographic atrophy (GA) treatment Izervay, this time in the US. The company has received a complete response letter (CRL) from the FDA for a ...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for IZERVAY™ ...

James reiterated its Strong Buy rating on Apellis Pharmaceuticals (NASDAQ:APLS), with a price target of $78.00. The stock, currently trading at $28.51, shows significant upside potential according to ...