Grace Halsey

The FDA has assigned a PDUFA action date of January 25, 2025 for the monthly IV maintenance dose.

The investigational combination vaccine elicited higher immune responses vs licensed comparator vaccines in 2 independent age groups, the company said.

GSK announced today approval by the US FDA of a label expansion for the adjuvanted RSV vaccine that adds adults aged 50 to 59 years who are at elevated risk for RSV disease to the vaccine’s current indication.

The registrational clinical trial met all endpoints related to androgen reduction and glucocorticoid dose reduction while maintaining androgen control.

Despite its limitations for use in other populations, a high BMI proved a very good predictor of dangerous fat mass index in youth aged 8 to 19 years in this study.

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.

The dual interleukin-4, 13 inhibitor reduced COPD exacerbation rates by as much as 34% for individuals with COPD with type 2 inflammation, Bhatt explains.

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.

Primary care clinicians are essential to maximizing evidence-based midlife care for women, according to Professor of Obstetrics & Gynecology JoAnn Pinkerton, MD.

The risk of mortality was not higher for women with vs without PMD overall but was particularly elevated for young women and for suicide across age of PMD diagnosis.

The novel dual neurokinin-1,3 antagonist reduced VMS after just 1 week of treatment, Pinkerton said, and improved sleep and quality of life, as well. Hear more.

Plozasiran, in the phase 2b MUIR trial, significantly reduced triglyceride and triglyceride rich lipoprotein levels through targeted action against APOC3.

The pluripotent GLP-1 mimetic reduced risk for renal disease endpoints by 24% and MACE by 18% plus significantly retarded decline in eGFR vs placebo, study authors reported.

The 3% decline in 2023 compared with 2022 is "heartening news," CDC's Houry says, but the mission is far from accomplished.

Adults with undiagnosed asthma or COPD who were randomly detected and assigned to specialist or usual care all had improved outcomes at 1 year, Canadian authors reported.

Women with class 3 obesity before becoming pregnant have up to a 4.5-fold greater risk of composite maternal morbidity that includes preeclampsia, preterm delivery, DM.

Dupilumab reduced COPD exacerbations by 34% in adults with uncontrolled symptoms and evidence of T2 inflammation, and significantly improved lung function.

Dave Singh, MD, lead investigator for the phase 2a COURSE trial of tezepelumab in moderate to very severe COPD, highlights the drug's promise in vulnerable groups.

ATS: The biologic shows promise in a range of people with COPD, particularly those with BEC levels of 150 cells/μL and greater, according to findings released at the 2024 ATS meeting.

The triple therapy cut risk of a first cardiopulmonary event by 20% vs dual therapy in addition to significantly reducing COPD exacerbations, PI Singh told Patient Care.

The 2 phase 3 trials met all primary and secondary endpoints, showing statistically significant reduction in symptoms and sleep disturbance and improvement in quality of life.

In the phase 1b trial, treatment with once-weekly subcutaneous CT-388 led to a statistically significant mean placebo-adjusted weight loss of nearly 20%.

Safety and HbA1c reduction with efsitora alfa dosed once weekly was comparable to both daily insulin degludec and daily insulin glargine, announced Lilly.

Analyses of the SELECT trial found mean weight loss of 10.2% sustained for 4 years and comparable CV benefit with weight loss greater or less than 5%, or even weight gain.

The company will present new data on effects of tezepelumab in COPD and of inhaled triple therapy Breztri on cardiopulmonary outcomes in COPD.

In average-risk individuals, the at-home ColoSense test demonstrated 93% sensitivity for detecting CRC and 45% sensitivity for detecting advanced adenomas.

AUA 2024. Neither use of alcohol nor vaping/cigarette smoking by either parent during preconception was "appreciably" linked to an incident event, new research found.

Study participants who had a history of stroke were nearly 60% less likely to meet guideline-recommended secondary prevention goals, new research reveals.

New research suggests the interval "could potentially be extended" without significant harms and could reduce unnecessary invasive procedures. , ie, missed early detection and CRC-specific mortality.