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 ...
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 ...
MedPage Today on MSN
Extended-Release Buprenorphine Viable, Safe During Pregnancy
Weekly injections led to higher opioid abstinence rate, with good infant outcomes ...
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 ...
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 ...
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