FDA News

FDA Approves Monthly Lecanemab for Early-Stage Alzheimer Disease: Daily Dose
February 04, 2025

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

Symbravo Mechanism of Action and Patient Selection, with PI Stewart Tepper, MD
February 04, 2025

Tepper, principal investigator for phase 3 trials of Symbravo as acute treatment for migraine in adults, reviews the new drug's dual MOA and target patient populations.

7 Drugs Approved for Primary Care: Q4 2024
January 31, 2025

An oral antibiotic for drug-resistant UTIs, a long-awaited therapy for congenital adrenal hyperplasia, and more.

Symbravo (AXS-07) for Treatment of Acute Migraine in Adults: Phase 3 Trial Primer
January 31, 2025

The pivotal INTERCEPT and MOMENTUM phase 3 clinical trials served as foundational evidence for the efficacy of the combination therapy across migraine presentations.

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.