FDA News

The updated COVID-19 vaccine targets the currently circulating Omicron variant JN.1 strain of SARS-CoV-2.

The Omnipod 5 is now the first automated insulin delivery system available for both T1D and T2D in the US.

The updated COVID-19 vaccines will include a monovalent component corresponding to KP.2, a strain of the Omicron variant of SARS-CoV-2.

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The First to Know Syphilis Test detects a current or past infection, regardless of successful treatment, in 15 minutes using a drop of blood.

The FDA recently accepted the sNDA for brexpiprazole in combination with sertraline and set a PDUFA target action date for February 2025.

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neffy (epinephrine nasal spray) is the first alternative to epinephrine administered by autoinjector or syringe and is comparable in efficacy to the gold standard.

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The Shield blood test is approved for primary CRC screening in adults 45 years and older at average risk for the disease.