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FDA

FDA Approves Ketamine for Surgical Pain Management

THe FDA has approved a new ketamine product for surgical pain management.

AUGUST 13, 2025

FDA Updates Opioid Labeling Requirements to Reflect Long-Term Risks

The FDA announced major changes to its opioid pain medication labeling regulations that better emphasize and ...

AUGUST 5, 2025

FDA Fast-Tracks BRTX-100 for Chronic Lumbar Disc Disease

The FDA has granted a fast track designation to the BRTX-100 program for the treatment of chronic lumbar disc ...

FEBRUARY 24, 2025

FDA Approves Combination Treatment for Acute Migraine With or Without Aura in Adults

The FDA has approved a combination of meloxicam and rizatriptan (Symbravo, Axsome Therapeutics) for the acute ...

FEBRUARY 10, 2025

Another Reason to Ask Patients What Supplements They’re Taking: Hepatotoxicity

Around 15.6 million adults in the US have taken at least one potentially hepatotoxic botanical in the past month, ...

JANUARY 23, 2025

FDA Details Continued Risk, Benefit Assessments of Devices for OUD

A committee is updating a 2019 risk−benefit analyses of devices to better understand patient preferences, and ...

JANUARY 2, 2025

Pros and Cons to Updating Biosimilar Switching Guidance

The FDA proposed removing the requirement that biosimilar drug manufacturers submit clinical switching studies to ...

NOVEMBER 15, 2024

FDA REMS Modification Advances Opioid Mail-Back Disposal Option

The FDA  will require participating companies to begin providing prepaid drug mail-back envelopes upon request ...

NOVEMBER 8, 2024

FDA Approves New Dose of Immediate-Release Oxycodone With Abuse-Deterrent Technology

The FDA has approved Roxybond  immediate-release Schedule II 10 mg for the management of pain severe enough to ...

OCTOBER 30, 2024

FDA Public Workshop to Focus on Analgesic Drug Development for Children

“Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of ...

OCTOBER 17, 2024

Is the Potential of Intrathecal Therapy Underappreciated?

Despite the anticipated benefits of intrathecal drug delivery, few specialists truly appreciate its potential.

OCTOBER 15, 2024

FDA Clears TENS Device for Pain Management

The FDA has cleared the use of the noninvasive medical device TensWave (Zynex) for pain management and ...

SEPTEMBER 6, 2024

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