The ID Pipeline: FDA Activity From the Week of April 19, 2020
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of April 19, 2020.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of April 19, 2020.
FDA Approves Sanofi's Quadrivalent Meningococcal Vaccine
The US Food and Drug Administration has approved a biologic license application for MenQuadfi meningococcal (Groups A, C, Y, W) conjugate vaccine. The approval was granted to Sanofi for the prevention of invasive meningococcal disease in persons 2 years and older.
MenQuadfi is the only FDA approved quadrivalent meningococcal vaccine that is indicated for individuals 2 through 56 years of age and older.
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FDA Grants EUA to LabCorp's At-Home COVID-19 Test Kit
The US Food and Drug Administration (FDA) has issued an emergency use authorization to LabCorp for at-home coronavirus disease 2019 (COVID-19) tests kits.
Under this authorization, nasal swab specimens can be collected at home using the Pixel by LabCorp COVID-19 collection kit. A health care provider must recommend the test and patients must complete a COVID-19 questionnaire prior to testing.
Read the full article.
