FDA News

Pain Expert Edward Mariano, MD, MAS, Highlights Journavx and the Newly-Approved Nonopioid's Mechanism of Action
January 31, 2025

Mariano, a well-known researcher in regional anesthesiology and acute pain medicine, talks about the Journavx difference, including the drug's safety profile.

FDA Approves First Monotherapy Standalone MDD Treatment: Daily Dose
January 31, 2025

Your daily dose of the clinical news you may have missed.

Journavx Approval: Lead Investigator Highlights Pivotal Phase 3 Clinical Trials
January 30, 2025

Todd Bertoch, MD, reviews the significant findings on relief of pain from the 2 pivotal studies and lauds the remarkable safety profile of the novel nonopoid analgesic Journavx.

FDA Approves Journavx, First-in-Class Nonopioid Analgesic for Moderate-to-Severe Acute Pain
January 30, 2025

Journavx is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years.

Axsome Therapeutics: FDA Approves Symbravo for Acute Treatment of Migraine
January 30, 2025

A single oral dose of Symbravo provided rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours.

FDA Grants Breakthrough Device Designation for Alzheimer Disease Blood Test
January 29, 2025

The Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test is designed to help identify patients with amyloid pathology associated with AD.

Lecanemab Monthly IV Maintenance Dosing: Research Highlights with R Scott Turner, PhD, MD
January 27, 2025

Georgetown University memory disorders expert R Scott Turner, PhD, MD, reviews the science behind approval of lecanemab for monthly maintenance dosing of lecanemab.

FDA Approves Mirikizumab for Crohn Disease: Daily Dose
January 27, 2025

Your daily dose of the clinical news you may have missed.

FDA Approves Monthly IV Maintenance Dosing of Lecanemab for Adults with Early Alzheimer Dementia: A First in Long-Term Disease Management
January 27, 2025

Once every four weeks maintenance dosing of lecanemab may be easier for patients and care partners to continue treatment.

FDA Clears Cobas Liat Assay Panels for Point-of-Care Diagnosis of Sexually Transmitted Infections
January 23, 2025

These test panels allow clinicians to diagnose multiple STIs from a single specimen, with results available in about 20 minutes.