FDA Grants Priority Review to PolyPid’s D-PLEX100 for Surgical Infection Prevention
PDUFA date set for Nov 28, 2026, triggering $15M milestone.
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PDUFA date set for Nov 28, 2026, triggering $15M milestone.
FDA aligns with CalciMedica on Auxora Phase 2b endpoints for acute pancreatitis, de-risking the path to registration.
Garmin raises full-year targets to $8.05B revenue and $10 EPS after Q2 sales hit $2.02B, led by 25% fitness growth from wearables demand.
Generac secures a second global supply deal with a hyperscale data center customer, lifting its backlog to $1.6B and powering strong Q2 growth.