H2 2025: Request meeting with FDA to discuss 505(b)(2) pathway. H2 2025: Target submission of New Drug Application (NDA). Sublingual ED medication H1 2026: Finalize formulation and manufacture test ...

Reaffirms guidance to resubmit the Anaphylm NDA in Q3 2026Received clarifying feedback from the FDA on pharmacokinetic (PK) and human factor (HF) ...

A randomized trial finds weekly extended-release buprenorphine yields neonatal outcomes comparable to sublingual treatment.

BioNxt Solutions has outlined a definitive timeline for the next stage of development for its sublingual drug delivery technology. The company's lead candidate, BNT23001, is a thin-film formulation of ...

H1 2026: Finalize formulation and manufacture test product. H1 2026 Initial Phase 1 pharmacokinetic clinical cross-over study. "Our pipeline is focused on research in therapeutic areas where we can ...

Weekly injectable buprenorphine is more effective than daily doses for treating opioid use disorder in pregnancy, with higher ...

What is nitroglycerin used for? Nitroglycerin is commonly used to treat and prevent chest pain caused by a type of heart disease (coronary artery disease). Nitroglycerin may also be used for other ...

VANCOUVER, BC / ACCESS Newswire / March 24, 2026 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery ...

The US Food and Drug Administration (FDA) has approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence, which may increase ...