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 ...

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

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 ...

Buprenorphine sublingual tablet is prescribed to treat opioid use disorder in two phases: an induction phase to manage initial withdrawal symptoms and a maintenance phase for long-term treatment. You ...

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 ...

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