Ryan Livingston

Results from the ATTAIN-MAINTAIN phase 3 study have displayed orforglipron’s efficacy in maintaining weight loss without major safety concerns.

Experts redefine obesity, distinguishing between preclinical and clinical forms, aiming to improve diagnosis and treatment strategies for better health outcomes.

Following the addition of a clinical study report to the NDA on December 12, the regulatory agency has extended the review period for the RASP inhibitor.

FDA approves lerodalcibep, a groundbreaking PCSK9 inhibitor, offering a monthly injection for LDL cholesterol reduction in patients with HoFH.

The FDA has approved etripamil nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia to sinus rhythm.

Announced by Cogent Biosciences, these data indicate bezuclastinib’s capacity for improving patient-reported symptoms of mast cell burden.

Catch up with major trial results, key clinician insights, and more.

Catch up with major FDA decisions, critical conference news, and more.

Results from the INTIMET study have shown no significant differences between metformin and placebo in liver, muscle, or adipose tissue insulin resistance.

The submission follows positive results from the BaxHTN trial, which saw the investigational aldosterone synthase inhibitor improve systolic BP versus placebo.

The acceptance comes on the heels of positive topline results comparing the new device to the current on-body infusor.

The investigational unimolecular GLP-1 and amylin receptor agonist substantially improved weight loss in a phase 2 trial.

Novo Nordisk has terminated the 1-year follow-up for the evoke and evoke+ trials after no significant reduction was indicated in either.

Bayer’s investigational FXIa inhibitor has proven its superiority to placebo in reducing ischemic stroke risk without increasing major bleeding rate.

The FDA has approved RNA interference therapeutic plozasiran for the treatment of familial chylomicronemia syndrome.

Data from 4 of the most impactful trials presented at the American Heart Association Scientific Sessions 2025.

Acoramidis also increased serum transthyretin in patients with wild-type ATTR-CM or the pathogenic variant ATTRv-CM.

Although the initial MACE composite outcome was not statistically significant, investigators saw follow-up MI risk reduced by >50%.

The SGLT2 inhibitor also displayed its efficacy in reducing left ventricular myocardial fibrosis and volume, as well as improving diastolic filling dynamics.

Data from the DECAF study suggests caffeine may have a slightly beneficial effect on AF recurrence, although investigators urge caution in interpretation.

REGN7508 and REGN9933 displayed their efficacy in preventing deep venous thromboembolism in patients undergoing knee replacement surgery in 2 phase 2 clinical trials.

This first-in-human phase 1 trial resulted in a groundbreaking reduction in both LDL cholesterol and triglycerides for the first time in history.

The investigative RNA-targeted antisense oligonucleotide achieved a reduction in fasting triglyceride of >72% in 6 months and sustained it through 12.

Adding evolocumab to existing lipid-lowering therapies significantly reduced first MACE risk, highlighting its efficacy in reducing cardiovascular mortality.

Research presented at the American Heart Association Scientific Sessions 2025 has emphasized the progress which still needs to be made in treating CHD.

Eli Lilly and Company’s investigative therapy provided effective and safe weight loss treatment with limited adverse events.

Catch up on the groundbreaking FDA approvals, key trial updates, and more news from the last month.

Stay up to date with the groundbreaking FDA decisions, critical trial updates, and more news from the last month.

Based on results from the THRIVE and THRIVE-2 phase 3 studies, this Biologics License Application includes a request for Priority Review.

Catch up with groundbreaking FDA decisions, exciting new GLP-1 news, and more.