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In Brief

FDA Approves Novel Nonopioid Treatment for Moderate-to-Severe Acute Pain

The FDA has approved suzetrigine (Journavx, Vertex Pharmaceuticals) 50 mg oral tablets as a first-in-class nonopioid analgesic to treat all types of moderate-to-severe acute pain in adults.  

JANUARY 31, 2025

NIH Ends Study of Tecovirimat as Mpox Pain Treatment

The NIH has halted a study testing tecovirimat as a treatment for patients with mpox after the drug showed no significant difference in reducing the time to lesion resolution or in influencing pain compared with placebo.

JANUARY 27, 2025

Better Algorithms Needed for Predicting Opioid Use Disorder

There is a need for more robust data and improved machine learning techniques to accurately assess the genetic risk of developing OUD, according to new research.

JANUARY 17, 2025

FDA Issues New Guidance, Clarifies Confusion on Buprenorphine Labeling

The FDA has issued new guidance for labeling buprenorphine-containing transmucosal products that seeks to clarify misinterpreted packaging.

JANUARY 16, 2025

FDA Grants 510(k) Clearance for Updated Cryoneurolysis System for LBP

The ioveraº system is an FDA-cleared, drug-free treatment that relieves pain via cryoneurolysis.

JANUARY 14, 2025

Patients, Providers Provide Perspectives on Opioid Diversion in Canada’s Safer Supply Programs

Safer pharmaceutical-grade alternatives to toxic and unregulated supplies of opioids could help address opioid diversion issues for patients to better prevent overdoses and other harms linked to the toxic drug supply.

JANUARY 9, 2025

FDA Approves Atogepant to Prevent Chronic Migraine in Adults

Atogepant becomes the first oral CRGP receptor antagonist approved to prevent both episodic and chronic migraine. 

APRIL 19, 2023

FDA Grants De Novo Status to Opioid Overdose Prevention and Alert System

Opioid Halo will be available OTC and by prescription

APRIL 12, 2023

FDA Accepts sNDA for Nerve Blocks in Lower Extremity Procedures

The label expansion would include single-dose sciatic nerve block in the popliteal fossa and femoral nerve block in the adductor canal.

APRIL 11, 2023

Biosimilar Approved to Treat Moderate to Severe RA

The FDA has approved rituximab-arrx for adults with moderate to severe active RA.

JUNE 8, 2022

FDA Grants sNDA Extension to Investigational Endometriosis Pain Drug

The FDA extended the review period for relugolix for the management of moderate to severe pain associated with endometriosis.

MAY 19, 2022

Upadacitinib Approved for Adults With Active Ankylosing Spondylitis

The FDA approved upadacitinib for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blocker.

MAY 4, 2022

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