SAN DIEGO — Patients with asthma who used depemokimab tolerated treatment well while experiencing reductions in rates of clinically significant exacerbations, according to a poster abstract ...

A Prescription Drug User Fee Act target date of December 16, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for review the Biologics License ...

for depemokimab for regulatory review in two indications. The proposed indications include add-on maintenance treatment for asthma in patients aged 12 and older with type 2 inflammation and an ...

The applications pertain to the use of depemokimab as an add-on maintenance treatment for asthma in patients 12 years and older with type 2 inflammation, and for adults with inadequately ...

GSK plc announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application for the use of depemokimab in two indications. The proposed indications are as add ...

The applications pertain to the use of depemokimab as an add-on maintenance treatment for asthma in patients 12 years and older with type 2 inflammation, and for adults with inadequately controlled ...

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Depemokimab’s PDUFA date is set for December ... The proposed indications are as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 ...

Depemokimab has already shown its potential as a therapy for severe asthma in two other phase 3 trials – SWIFT-1 and SWIFT-2 – and GSK is in the process of preparing regulatory filings for the ...