The report "Catalyst Monitor Q4 2025" highlights upcoming market opportunities in biotech and pharma, focusing on key approvals and trials such as Cytokinetics’s aficamten, Aldeyra’s reproxalap, and ...
GSK’s GSK two-phase III studies, which evaluated depemokimab for treating severe asthma characterized by type II inflammation, met their primary endpoints. The primary endpoints of the SWIFT-1 and ...
Depemokimab has high binding affinity and potency for IL-5. Eosinophils fell by 83% and 82% with treatment in the two trials. The treatment and placebo groups had similar rates and types of adverse ...
On Monday, GSK plc (NYSE:GSK) released headline results from the phase 3 trials ANCHOR-1 and ANCHOR-2, which assessed the efficacy and safety of depemokimab versus placebo in adults with chronic ...
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 Application ...
If approved, depemokimab will be the first ultra-long-acting biologic with 6-month dosing Submissions based on data from positive SWIFT and ANCHOR trials SWIFT-1 and -2 showed depemokimab reduced ...
GSK plc GSK recently announced that EMA has accepted the regulatory filing seeking approval for its IL-5 inhibitor depemokimab in two respiratory indications – asthma with type II inflammation and ...
MISSISSAUGA, ON, May 26, 2025 /CNW/ - GSK has submitted a New Drug Submission (NDS) to Health Canada for depemokimab for two proposed indications: The first indication is as an add-on maintenance ...
ANCHOR-1 and ANCHOR-2 phase III trials show improvements in nasal polyp size and obstruction for depemokimab with twice-yearly dosing versus placebo Results with depemokimab were observed early at ...