The resubmitted NDA for sotagliflozin for adults with T1D and CKD included post hoc analyses from the TANDEM clinical development program and post hoc analysis from the SCORED trial.

Concizumab is a tissue factor pathway inhibitor antagonist that enhances factor Xa production during the initiation phase of coagulation. This production improves thrombin generation and clot ...

The Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one ...

Results from the VENTURE trial showed significant reductions in weight and hunger among younger patients treated with ...

CBD did not meet primary end point comparing preingestion to postingestion anxiety, but resulted in lower anxiety levels ...

Veligrotug is an investigational monoclonal antibody that inhibits the activity of insulin-like growth factor-1 receptor.

(HealthDay News) — Light-to-moderate consumption of wine, measured through an objective urinary biomarker, is associated with lower cardiovascular disease (CVD) risk in an older Mediterranean ...

The FDA is recommending an additional clinical trial to confirm glepaglutide’s efficacy and safety at the to-be-marketed dose.

(HealthDay News) — The use of influenza testing at hospital emergency department visits increased from 2013 to 2022 in the United States, according to a December data brief published by the National ...

The prescribing information for Veozah (fezolinetant) has been updated to include a boxed warning regarding the risk of hepatotoxicity, following the Food and Drug Administration’s review of a ...

ACIP recommends extending interval for two-dose series and adding three-dose series in accordance with FDA label ...

The BLA acceptance was supported by data from the randomized, placebo-controlled phase 2b/3 CLEVER trial as well as interim ...