Aquestive Therapeutics Gets FDA CRL for Anaphylm, Eyes Q3 Resubmission After Human Factors Fixes

Executives from Aquestive Therapeutics (NASDAQ:AQST) said the U.S. Food and Drug Administration has issued a complete ...
MPR

FDA Cites Pouch Design and Labeling Deficiencies in Anaphylm CRL

The FDA has requested new human factors and pharmacology studies for Anaphylm sublingual film following deficiencies in original NDA packaging data.
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 ...
The Herald-Palladium

Mentavi Health Reflects on a Defining 2025 and Outlines Responsible Growth Plans for 2026

Peer-reviewed validation study, expanding institutional adoption, and human-centered innovation reinforce Mentavi's leadership in mental health care ...
Nasdaq

Clinical Validation Study on Natera’s Fetal RhD NIPT Published in Obstetrics & Gynecology

Test demonstrated high performance metrics in largest study of its kind in the US with sensitivity of 100% and specificity of 99.3% Natera’s study is the largest clinical validation of a fetal RhD ...