FDA News

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.

Pivmecillinam is an aminopenicillin, a class of beta-lactam antibiotics with a mechanism of action that may help reduce rising levels of antibiotic resistance.

Vedolizumab for subcutaneous injection in now indicated for maintenance therapy following IV induction in both Crohn disease and ulcerative colitis.