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The FDA has approved the first generic once-daily GLP-1 injection for the improvement of glycemic control for type 2 diabetes in patients 10 years and up.

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

The black box warning, the agency's most prominent alert, follows earlier additions to the original fezolinetant label about hepatic injury and regular LFT testing.

This marks the second indication for tirzepatide in just more than a year, following its November 2023 approval for adults with obesity or overweight and weight-related medical problems.

People with hypertension who adhered to the mobile app demonstrated well-controlled blood pressure over a 12-week observational period.

The first in class CRF-1 receptor antagonist allows people with CAH to reduce glucocorticoid doses while androgen levels are maintained or improved.

The 22.7% weight loss at 68 weeks places CagriSema essentially on par with, not superior to, competing antiobesity drugs including Lilly's tirzepatide.

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

In the largest twin-sibling study to date of the inherited biological risk of PTSD, researchers found additive genetic and unique environmental effects contributed to the disorder.

Pain relief with suzetrigine was comparable to that seen with placebo, an issue Vertex plans to address with study design as the drug moves to the pivotal phase 3 trials.

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.