FDA News

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

Your daily dose of the clinical news you may have missed.

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.

Your daily dose of the clinical news you may have missed.

While Moderna expects mRNA-1345 to be approved later this month, the company cites FDA administrative constraints as reason for delay.

The AdComm plans to review data from the TRAILBLAZER-ALZ 2 phase 3 clinical trial that served as the foundation for Eli Lilly's original BLA submission to the FDA.

In average-risk individuals, the at-home ColoSense test demonstrated 93% sensitivity for detecting CRC and 45% sensitivity for detecting advanced adenomas.

The sNDA for the brexpiprazole plus sertraline therapy is based on positive phase 2 and 3 clinical trials showing improvement in PTSD-specific scale scores.