Small Doses: March 4 to March 8

Benzene Found in Acne Products From Major Brands, Prompts FDA Recall Petition

High levels of the cancer-causing chemical benzene were found in various benzoyl peroxide acne products from major brands, including Proactiv, Clinique, Clearasil, and more.

Valisure LLC, an independent testing laboratory, filed a petition with the FDA requesting a recall of treatments affected by elevated levels of the carcinogen in order to allow regulators to investigate.

FDA Grants Breakthrough Therapy Designation to LSD-Based Treatment for Generalized Anxiety Disorder

Mind Medicine has received breakthrough therapy designation from the FDA for its lysergide d-tartrate (MM120) therapy to treat generalized anxiety disorder.

The breakthrough therapy designation was granted based on the MMED008 study that demonstrated improvements on the Hamilton Anxiety rating scale compared to placebo.

HHS Says It’s Working to Help Those Impacted by Change Healthcare Cyberattack

The United States Department of Health and Human Services released a statement Tuesday that addresses the cyberattack on Change Healthcare.

The attack was performed by a group of hackers who stole patient data and other important information, and caused an outage at the company that left numerous hospitals and healthcare providers unable to bill for services.

Tocilizumab-aazg Is First IV, Subcutaneous Tocilizumab Biosimilar With FDA Approval

Following FDA approval, Fresenius Kabi’s tocilizumab-aazg (Tyenne) has become the first tocilizumab (Acterma) biosimilar with an intravenous and subcutaneous formulation.

It represents a comprehensive, accessible, and high-quality treatment option for patients in the US treated with tocilizumab.

FDA Grants Accelerated Approval to Zanubrutinib for R/R Follicular Lymphoma

The FDA has granted accelerated approval to zanubrutinib (Brukinsa) with obinutuzumab for the treatment of relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

This is the fifth oncology indication for zanubrutinib in the US; it is the first and only FDA approved BTK inhibitor approved for follicular lymphoma.