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

The addition, based on an approved update to labeling, expands to 4 the recommended vaccination options that health care professionals can offer to pregnant people.

The 2 novel vaccine candidates each combine a Sanofi licensed influenza vaccine with the Novavax adjuvanted recombinant COVID-19 vaccine.

The potential adverse outcomes include asthma, food allergies, cerebral palsy, and cancer, according to a recent systematic review and meta-analysis.

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

If approved, the nonopioid, centrally acting analgesic would be the first in a new class of medications for fibromyalgia in more than 15 years, Tonix said.

The lead investigator of the largest clinical trial program in people with CAH discusses the condition, its burden, and the novel drug just approved that will change lives.

Clesrovimab, if approved, would be the only immunization for both healthy and at risk infants using the same dose. FDA set A PDUFA date of June 2025.

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

Nemolizumab is the first approved monoclonal antibody that targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives disease mechanism in atopic dermatitis.

Find details on US colorectal cancer screening rates, dietary interventions for people with IBS, and research on the primary drivers of cost of IBD care.

Approval for the topical nonsteroidal therapy, based on data from the phase 3 ADORING clinical trial program, helps fill a gap in current offerings for atopic dermatitis.

Auchus details findings from the unique study of the CRF-1 antagonist crinecerfont, the first new therapy for CAH approved in 70 years.

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

The coverage with evidence development (CED) policy requires enrollment in an active clinical trial for an adult to be eligible for Medicare coverage of treatment for Alzheimer's disease.

Crinecerfont approval makes available the first new treatment for the life-altering endocrine disorder in more than 70 years, according to Neurocrine Biosciences.

A phase 1b and Phase 2 study are up next for the novel potential MDD treatment.

Intra-Cellular Therapies submitted an sNDA to the FDA for lumateperone for the treatment of MDD in adults as as adjunctive therapy to antidepressants.