FDA News

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.

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

Following the landmark FDA approval of resmetirom for MASH with fibrosis, hepatologist and researcher Alkhouri describes more mid- and late-stage candidates.

Naim Alkhouri, MD, a transplant hepatologist and a resmetirom investigator, talks here about the life-changing impact the drug will have for all touched by MASH.