May 2024 FDA News: Approvals, Grants, Outbreaks, and More


FDA approves self-test for HPV, FDA food recalls due to illness outbreaks, FPA approved mpox vaccine available for purchase in the US, and more this month from the FDA.

The FDA grants Breakthrough Device Designation to Karius Test to Assist in Diagnosing Infectious Diseases

This genomic diagnostic tool aims to support diagnosis, particularly in immunocompromised patients by identifying pathogens associated with pneumonia and other lung infections.

FDA Approves Self-Test for HPV

The federal agency gave the nod to Roche’s human papillomavirus (HPV) self-collection and gives women the ability to gather their own samples in a healthcare setting, which can then be sent off for lab results. Screening for HPV can help identify women who are at risk of developing cervical cancer.

FDA Issues CRL for Dynavax's HEPLISAV-B Four-Dose Regimen in Hemodialysis Patients

Dynavax is currently reviewing FDA feedback and strategizing a meeting to discuss their HEPLISAV-B 4-dose regimen, because of insufficient data to assess the effectiveness or safety of the regimen fully, for hemodialysis patients, determining the path forward toward approval.

The FDA in collaboration with the Centers for Disease Control and Prevention (CDC) and state and local health partners, are investigating a multistate outbreak of E coli O157:H7 infections linked to organic walnuts.

Mpox Vaccine is 99.2% Efficacious Against Infection

The vaccine, Jynneos (Bavarian Nordic), is an FDA-approved vaccine for mpox, and is now available for commercial purchase in the United States. The Jynneos vaccine is highly effective in preventing Mpox virus infection after receipt of 2 Jynneos doses. In fact, the estimated incidence rate to have occurred is less than 0.8% in fully vaccinated persons.

The FDA announces the voluntary recall of Hy-Vee Cream Cheese Spread due to the potential contamination of Salmonella.

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