- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
Aquestive, led by Dan Barber, received a determination from the FDA regarding its drug development process.
5 reports, 2 independent
Updated Aug 12
Gone quiet
- Reports
- 5
- Developments
- 2
- Repetition
- 60%
New informationRepeats or wire copies
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What happened
Aquestive, led by Dan Barber, received a determination from the FDA regarding its drug development process.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.Dan Barber oversees resubmission plans to the FDA for UK and Europe.1 source
FDA determined advisory committee meeting is not required for Aquestive.1 source
Keep 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
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- 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
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Aquestive (United States)
company in Warren Township, United States
Nothing else this week.
- FDA
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Coverage
Newest first; wire copies grouped- yahoo.com
- GlobeNewswireAquestive Therapeutics Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for Anaphylm™ NDA remains on track for FDA PDUFA goal date of January 31, 2026
- GlobeNewswireAquestive Therapeutics Announces $75M Strategic Funding Agreement with RTW to Support the Potential Launch of Anaphylm™ (epinephrine) Sublingual Film Anaphylm launch funding of $75 million committed
- GlobeNewswireAquestive Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update FDA accepts NDA submission for Anaphylm™; PDUFA date set for January 31, 2026 Planning continues for
- GlobeNewswireAquestive Therapeutics Names Sherry Korczynski as Chief Commercial Officer WARREN, N.J., July 22, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”),