- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
FDA lifted clinical hold on MARIO study and transferred the BREXAFEMME NDA to GSK.
1 report, 1 independent
Updated Aug 14
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What happened
FDA lifted clinical hold on MARIO study and transferred the BREXAFEMME NDA to GSK.
Who's involved
What this event is mainly aboutKeep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- A partnership with BARDA has accelerated the development of SCY-247 for the company.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
- FDA
-
Scynexis
company in Durham, United States
-
GSK
British multinational pharmaceutical and biotechnology company
Related events
- FDA removed the clinical hold on Arbutus Biopharma Corporation's IND application, allowing potential clinical development.
- Litigation regarding FDA approval process.
- FDA accepts a BLA for biosimilar review and extends its review process to Health Canada.
- Zenith collaborates with Harvard researchers on clinical studies, receiving FDA clearance for the trial.
- The FDA is reviewing the BLA submission from Ultragenyx Pharmaceutical, with Eric Crombez serving as chief medical officer.
Coverage
Newest first; wire copies grouped- GlobeNewswireSCYNEXIS Reports Second Quarter 2025 Financial Results and Provides Corporate Update First new patient dosed in Phase 3 MARIO study following the lifting of the FDA clinical hold, triggering a $10M m