- 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
AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.
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
Nothing else this week.
-
GSK
British multinational pharmaceutical and biotechnology company
Related events
- FDA issued a partial clinical hold on trials involving Biohaven Ltd. on September 11, 2026.
- The FDA placed a clinical hold on the IND application for the company Aardvark.
- A study protocol involving a company based in Mont-Saint-Guibert was approved by the U.S. FDA.
- FDA approval enables commercial opportunity involving CBRE Group.
- Litigation regarding FDA approval process.
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