FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject ...
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 ...
The first sublingual therapy for the intermittent treatment of uncontrolled OFF episodes for adult people living with Parkinson’s Disease ...
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 ...
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 ...
A review in the Annals of Pharmacotherapy examined the literature on alternative routes of administration for antipsychotic and antidepressant medications via inhaled, intranasal, buccal, sublingual, ...
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 ...
The FDA has accepted for review the resubmitted New Drug Application (NDA) for apomorphine sublingual film (APL-130277; Sunovion) for the treatment of OFF episodes in patients with Parkinson disease ...
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 ...
Prioritizes High-Value Approved Drugs in Multi-Billion-Dollar Markets to Accelerate Commercialization Future Platform Expansion into CNS, Men's Health, and Anti-Nausea ESTERO, FL / ACCESS Newswire / ...
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