FiercePharma1d
Astellas' eye med Izervay lands key FDA label update, amping up market battle with Apellis rival
In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med ...
Managed Healthcare Executive1d
FDA Approves Expanded Label for Izervay, No Dosing Duration Limit
The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic ...
The Pharma Letter1d
Wider label approved for Izervay by FDA
The US Food and Drug Administration (FDA) approved expanding the prescribing information for Japanese drugmaker Astellas ...
U.S. FDA Approves Expanded Label for Astellas' IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy
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™ ...
pharmaphorum2d
FDA changes its mind on Astellas' geographic atrophy drug
Marci English, head of biopharma and ophthalmology development at Astellas Pharma, said the FDA's change of heart will ...
Pharmabiz1d
US FDA approves expanded label for Astellas’ Izervay for the treatment of geographic atrophy
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 ...
Monthly Prescribing Reference1d
Izervay Label Update Removes Limit on Treatment Duration for Geographic Atrophy
The Food and Drug Administration (FDA) has expanded the labeling for Izervay™ (avacincaptad pegol intravitreal solution) to include longer-term ...
FiercePharma9d
Astellas takes $760M charge, reveals slowdown for eye drug Izervay after regulatory stumbles
Navigating regulatory hurdles in the U.S. and Europe, plus fierce competition from rival Apellis, Astellas’ geographic ...
Morningstar2d
U.S. FDA Approves Expanded Label for Astellas' IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy
"We are pleased with the FDA's decision to extend the use of IZERVAY for longer-term administration—further solidifying IZERVAY's status as a trusted choice for thousands of GA patients since ...
U.S. FDA Approves Expanded Label For Astellas' IZERVAYTM (Avacincaptad Pegol Intravitreal Solution) For Geographic Atrophy
IZERVAY dosing approved beyond 12 monthsTOKYO, Feb. 12, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Ok ...