Aquestive receives FDA CRL for Anaphylm allergic reaction treatment

Aquestive Therapeutics has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding ...

Leerink sees ‘silver lining’ in Aquestive CRL given defined path to approval

Leerink analyst Roanna Ruiz was not surprised that Aquestive Therapeutics (AQST) received a Complete Response Letter for ...
The American Journal of Managed Care

FDA Flags Administration Concerns for Aquestive's Noninvasive Epinephrine Film

Aquestive Therapeutics announced it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Anaphylm (dibutepinephrine) Sublingual Film, a noninvasive ...
Seeking Alpha

Aquestive Therapeutics Announces Completion of FDA End-of-Phase 2 Meeting For AQST-109 (epinephrine sublingual film)

FDA continues to indicate that the Company can conduct a comparability study rather than efficacy studies FDA provides clear guidance on approvability expectations for pharmacokinetic (PK) performance ...
Seeking Alpha

Lexeo Therapeutics Reports Third Quarter 2025 Financial Results and Operational Highlights

FDA open to pooling data from ongoing Phase I/II studies of LX2006 with data from pivotal trial, and to earlier co-primary endpoint assessment, to support a Biologics License Application FDA approved ...