FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...

Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time Receives ...

A Prescription Drug User Fee Act target date of January 31, 2026 has been set for the application. The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for epinephrine ...

Format Comparison for Needle-Free GLP-1 Options, Administration Preferences, and Telehealth Access PathwaysHOUSTON, TX, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Disclaimer: This article is for informational ...

Findings showed MELT-300 was statistically superior to both sublingual midazolam and placebo for providing successful procedural sedation. Topline results were announced from a phase 3 trial ...

Bial has introduced a new sublingual formulation of apomorphine in the UK, offering a fresh treatment option for adults with Parkinson’s disease who experience intermittent OFF episodes that are not ...

Allergies have plagued over 100 million Americans, presenting a pervasive issue across the nation. Despite the widespread prevalence of allergies, the available treatment options are limited.

For acute ischemic stroke within 48 hours of onset, the novel sublingual combination of edaravone (Radicava) with dexborneol appeared to dramatically improve functional outcomes in the phase III TASTE ...

Daily administration of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM-SLIT) appears to be a safe and efficacious option for treating house dust mite (HDM) in younger children with ...

The first sublingual therapy for the intermittent treatment of uncontrolled OFF episodes for adult people living with Parkinson’s Disease ...

Aquestive Therapeutics has announced encouraging data regarding Anaphylm, its investigational sublingual epinephrine film designed for treating severe allergic reactions. New results indicate that ...

VANCOUVER, BC / ACCESSWIRE / December 2, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience company specializing in advanced drug delivery ...