FDA News and Regulatory Updates

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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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.

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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.

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Bempedoic acid became the first nonstatin LDL-C lowering medication indicated to reduce CV risk in both primary and secondary prevention. Nissen explains how.

The additional indication for benralizumab was supported by data from the phase 3 TATE trial.

The Low EF AI is designed to detect low ejection fraction in 15 seconds during a primary care exam.

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

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

Specifically, the topical analgesics, available over the counter, may contain higher than labeled concentrations of lidocaine, according to the agency.

The FDA approved the oral medication to treat anemia in adult patients with chronic kidney disease on dialysis for at least 3 months.

For the first time, 2 drugs recommended as first line treatment for PAH are combined in a single oral once-daily therapy, which could reduced burden of care.