Brief: Tetratherix Receives Substantive FDA Review Update For Tegenix 510(K) Submission
06/10/2026 02:04
BRIEF-Tetratherix Receives Substantive FDA Review Update For Tegenix 510(K) Submission Oct 6 (Reuters) - Tetratherix Ltd TTX.AX:
RECEIVES SUBSTANTIVE FDA REVIEW UPDATE FOR TEGENIX 510(K) SUBMISSION
FDA CONFIRMS DEVICE CLASSIFICATION, PREDICATE DEVICE, AND PERFORMANCE DATA FOR TEGENIX
FDA REQUESTS EXTRA DETAIL ON CHEMICAL CHARACTERISATION AND PRODUCT LABELLING FOR TEGENIX
Further company coverage: TTX.AX
((Reuters.Briefs@thomsonreuters.com;))
Recent news on Tetratherix
See all newsBrief: Tetratherix Receives Substantive FDA Review Update For Tegenix 510(K) Submission
Australia's Tetratherix rises after FDA review update on Tegenix application
Brief: Tetratherix Receives Firm Commitments For A$15 Million Placement At Issue Price Of A$6
Brief: Tetratherix Requests Trading Halt
Australia's Tetratherix rises on nasal delivery deal of GLP-1 in US market