Brief: Virogates Receives FDA Feedback On 513(G) Request

ViroGates A/S

17/10/2025 13:38

Oct 17 (Reuters) - ViroGates A/S VIROG.CO:

VIROGATES RECEIVES FDA FEEDBACK ON 513(G) REQUEST, CONFIRMING REGULATORY PATHWAY FOR U.S. MARKET ENTRY

FDA INDICATES SUPARNOSTIC® TURBILATEX FOR DE NOVO CLASSIFICATION

AIMS TO FILE FDA CLEARANCE IN Q4 2025 OR Q1 2026

Source text: ID:nMFN4DFjtq

Further company coverage: VIROG.CO

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