FDA News

Among youth aged 10 to 17 years with uncontrolled hyperglycemia dapagliflozin led to a statistically significant reduction in A1c vs placebo in the T2NOW phase 3 clinical trial.

Capvaxive is the only pneumococcal vaccine formulated specifically to protect adults 50 years and older from IPD and elicited robust immune responses in both vaccine-naïve and vaccine-experienced adults.

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The investigational combination vaccine elicited higher immune responses vs licensed comparator vaccines in 2 independent age groups, the company said.

Abbott becomes the second company to receive FDA clearance for an over-the-counter continuous glucose monitoring system.

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The over-the-counter antigen test, for use at home or at point of care, discriminates between SARS-CoV-2 and influenza A and B in 15 minutes.

mRESVIA is Moderna's second mRNA-based vaccine and will be shipped in prefilled syringes, a desirable feature that could save clinical time, prevent errors.

FDA has no concerns about the "approvability" of dupilumab for the new indication but needs additional time to review phase 3 data it requested early in May.

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