Aspire Biopharma Submits Pre-IND Meeting Request and Briefing Package to U.S. FDA for Sublingual Aspirin Product for Treatment of Suspected Acute Myocardial Inf…

ESTERO, FLORIDA / ACCESS Newswire / December 2, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) (“Aspire” or the ...
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Aspire Biopharma Announces Milestone Roadmap Targeting H2 2025 FDA Submission for Sublingual Aspirin and Key 2026 Milestones for Needle-Free Semaglutide (Diabetes, Weight ...

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 ...
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First new fibromyalgia drug in 15 years, Tonmya (cyclobenzaprine HCl) gains FDA approval and hits pharmacy shelves

In a milestone moment for chronic pain management, Tonix Pharmaceuticals announced on August 15, 2025, that its novel ...

Aspire Biopharma Provides Q3 2025 Business Update

ESTERO, FL / ACCESS Newswire / December 4, 2025 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) (“Aspire” or the “Company”), ...
KXAN

BioNxt Reports Sublingual Cladribine Multiple Sclerosis Drug Milestones Including Large-Animal Study for Validation and Dosing Optimization

VANCOUVER,BC / ACCESS Newswire / September 29, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience company specializing in innovative drug delivery ...
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BioNxt Provides Update on Cladribine Program for Multiple Sclerosis, Sublingual Neurodegenerative Disease Patent, and Investor Relations Activities

VANCOUVER, BC / ACCESSWIRE / September 26, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) is pleased to provide an update on its flagship sublingual ...
Business Wire

Sunovion Announces FDA Acceptance of New Drug Application for Apomorphine Sublingual Film (APL-130277)

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ...
Medscape

FDA Clears First Generic Versions of Suboxone Sublingual Film

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 ...
Healio

Sublingual epinephrine film pharmacokinetics similar in pediatric, adult patients

Pharmacokinetic and pharmacodynamic data of Anaphylm sublingual epinephrine film in pediatric patients were similar to data reported in adults, according to phase 1 study results.This study on ...
Morningstar

Aspire Biopharma Announces Milestone Roadmap Targeting H2 2025 FDA Submission for Sublingual Aspirin and Key 2026 Milestones for Needle-Free Semaglutide (Diabetes, Weight ...

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 ...