Aquestive received an FDA rejection for its allergy film due to safety and use issues. The company plans new studies and ...
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 ...
Deficiencies limited to packaging and administrationCompany believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 2026Remains well-capitalized and anticipates ending 2026 ...
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 ...
A new study published in Therapeutic Innovation & Regulatory Science provides crucial insights into the design and implementation of multi-national observational studies for post-marketing drug safety ...
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