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 ...
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 ...
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 ...
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 ...
FiercePharma22h
Fierce Pharma Asia—Astellas' investment focus; Mitsubishi Tanabe's buyout; Leqembi's 'expansion phase'
Astellas is shifting its investment focus toward more established modalities and later-stage opportunities, its chief ...
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 ...
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™ ...
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 ...
FierceBiotech11d
Astellas fires CSO and chief manufacturing officer in C-suite shake-up
Chief Scientific Officer Yoshitsugu Shitaka, Ph.D., won’t be so lucky. Astellas intends to create the new role of chief ...
Raymond James maintains Strong Buy on Apellis shares, target at $78
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 ...
Yahoo Finance9d
Astellas seeks conditional approval for GA treatment in Japan
Astellas Pharma has submitted a new drug application ... ACP has already been approved in the US for the same indication under the brand name Izervay. The therapy functions as a synthetic aptamer ...
Astellas Pharma Inc.: U.S. FDA Approves Expanded Label for Astellas' IZERVAY (avacincaptad pegol intravitreal solution) for Geographic Atrophy
IZERVAY dosing approved beyond 12 months TOKYO, Feb. 12, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today ...