Brief: Enorama Pharma Gets FDA Statement In Ongoing US Court Proceedings
BRIEF-Enorama Pharma Gets FDA Statement In Ongoing US Court Proceedings Sept 10 (Reuters) - Enorama Pharma AB ERMA.ST:
RECEIVES FDA STATEMENT IN ONGOING U.S. COURT PROCEEDINGS
FDA REFUSE-TO-FILE DECISION ON ENORAMA PHARMA'S PMTA APPLICATION UNDER SECTION 910(B)
FDA TO PROVIDE ADMINISTRATIVE RECORD RELATED TO RTF DECISION BY OCTOBER 9, 2026
U.S. DISTRICT COURT TO SET SCHEDULE FOR FURTHER PROCEEDINGS AFTER RECORD IS PROVIDED
Source text: ID:nWkr6Ky3CC
Further company coverage: ERMA.ST
(Gdansk Newsroom)
((gdansk.newsroom@thomsonreuters.com; +48 58 769 66 00;))
Recent news on Enorama Pharma AB
See all newsBrief: Enorama Pharma Signs Agreements For Nic-S Tobacco-Free White Snus
Brief: Enorama Pharma Gets FDA Statement In Ongoing US Court Proceedings
Brief: Enorama Pharma Q2 Operating Loss SEK 11.7 Mln
Brief: FDA Upholds Refuse-To-File Decision On Enorama Pharma's PMTA Applications
Brief: Enorama Pharma Names Amy Walker New Interim CEO