Grace Halsey

Positive findings from a repeat dosing study of neffy under nasal allergen challenge conditions will support a potential PDUFA date of October 2, 2024, the company said.

The quality performance measure is viable and reliable and could help improve early CRC detection rates via timely colonoscopy following abnormal stool-based test.

Atogepant was associated with fewer monthly migraine days, fewer acute medication use days, and greater QoL compared with rimegepant after 12 weeks.

ACC.2024: Two abstracts presented during the ACC Scientific Sessions indicate cardiologists are very hesitant to prescribe medical therapy for obesity.

ACC.24: Loss of estrogen's cardioprotective effect could account for the 2-fold greater increase in CAC score seen among postmenopausal women compared with men.

The study looked at the impact over 3 years but found that most of the averted burden, including more than 8000 fewer deaths, occur in the first year after vaccination.

ACC.24: Icosapent ethyl was associated with reduced rate of MACE at all baseline levels of Lp(a) in participants with elevated TG and at high risk for CVD.

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

The mRNA bivalent vaccine candidate produced a "more robust" immune response vs Spikevax and particularly in adults over the age of 65 years, said Moderna.

The once daily tablet, VK2375, is headed to a phase 2 trial later this year and is an oral version of Viking's investigational injectable GLP-1/GIP mimetic currently in phase 2.

CLEAR Outcomes PI Steven Nissen, MD, links findings from the pivotal trial with labeling updates that make bempedoic acid the only nonstatin agent approved to reduce CV risk.

The novel SGLT-2/SGLT-1 inhibitor reduced risk of stroke, MI, and demonstrates significant antiplatelet activity in post-hoc analyses of SCORED phase 3 trial.

ACC.2024: In a cohort of people at high risk of ASCVD, three-quarters achieved target LDL-C levels at 6 months and 12 months while using a remote algorithm-directed program.

Overall, a 33% increased risk of major bleeding was seen, with risk highest during the first 30 days of concomitant use and persistent, but lower, after 6 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.

Bempedoic acid is now the only non-statin therapy indicated for primary CVD prevention, with potential to expand treatment access to millions, said Esperion Therapeutics.

CMS says Medicare Part D plans will cover semaglutide for individuals with overweight/obesity who have preexisting CVD, a first after 40 years of legal prohibition.

Cologuard Plus bests previous iteration and demonstrates greater sensitivity and specificity for any CRC relative to fecal immunochemical tests.

Long COVID affects approximately 20 million people in the US and that number may be conservative. Here, a snapshot, through the fog, of the route they are on.

LEGEND phase 2 interim analysis findings include significant decreases in HbA1c in poorly controlled T2D and positive effects on several markers of liver injury.

Aprocitentan is the first antihypertensive drug approved in more than 30 years that achieves its effect through a unique therapeutic pathway.

Adults with asthma are at significantly increased risk for a range of comorbidities including COPD, rhinosinusitis, atopic dermatitis, and GERD that may affect disease management and cost of care.

The novel 21-valent pneumococcal vaccine remains on track for the FDA PDUFA date of June 17, 2024; Merck adds this new data to the body of positive evidence.

Findings from the ECLIPSE clinical trial showed the blood-based cancer screening test detects 83% of people with CRC, with a specificity of 90%.

Now FDA approved, Optinose’s Xhance is the first nonsurgical option for chronic rhinosinusitis both with and without nasal polyps.

Resmetirom is the first-ever drug to be approved anywhere for management of the progressive liver disease.

THARROS is the first phase 3 RCT to evaluate an inhaled triple combination therapy for reduction of adverse cardiopulmonary events in people with COPD, says AstraZeneca.

The KDIGO 2024 CKD Practice Guideline is the first update since the 2012 iteration and so is based on the newest research on treatment and technology available.

Ionis reports the first clinical evidence that DGAT2 inhibition-driven reduction of hepatic fat correlates with improvements in MASH histologic endpoints.

The 2 phase 3 trials in the 89bio ENLIGHTEN clinical trial program will evaluate the safety and efficacy of the FGF21 analog in MASH, fibrosis.