Connor Iapoce

Announced by LIB Therapeutics Inc., the agency has set a PDUFA target action date of December 12, 2025.

Use of medications for secondary CVD prevention is low globally, and in most country income-level groups, with no indication of improvement.

More than 90% of patients with hemophilia B eliminated factor IX prophylaxis 4 years after treatment with etranacogene dezaparvovec (HEMGENIX) gene therapy.

Interim analysis of the Phase 3 FRONTIER3 trial found Mim8 well-tolerated in children with hemophilia A with and without inhibitors.

SGLT2 inhibitors lower the risk of MACE in older age, despite smaller HbA1c reductions, while GLP-1 RAs were more cardioprotective in younger individuals with T2D.

The January 2025 ophthalmology month in review highlights the latest from the FDA, key updates to the ophthalmic pipeline, and the latest episode of New Insight.

Both doses of DURAVYU extended the time to the first supplemental injection versus aflibercept control in the Phase 2 VERONA trial.

Elevated HDL-C raised glaucoma risk, particularly for participants aged ≥55 years, contrary to its typical beneficial role in cardiovascular health.

The FDA’s approval marks the second indication for Genentech's refillable ocular implant in addition to wet age-related macular degeneration.

The January 2025 endocrinology month in review highlights the latest from the FDA, key drug price negotiations, and the latest updates to the obesity pipeline.

Lipid screening after bulk orders and outreach letters increased significantly at 3 months, but supplemental text messaging had no further impact.

The January 2025 cardiology month in review highlights new NDA acceptances, clearance of the first Lp(a) test in molar units, and national trends in preventive aspirin use.

Once-weekly tirzepatide may be an alternative to daily hormone shots in patients with congenital generalized lipodystrophy.

This FDA News Month in Review provides a round-up of regulatory decisions and submissions from January 2025.

Awarded to Beacon Therapeutics, RMAT designation allows enhanced communications with the FDA across the development of the investigational gene therapy.

The American Heart Association’s 2025 statistical update confirms cardiovascular diseases claim more US lives than all forms of cancer and accidental deaths.

Merck announced robust efficacy data on the benefit of sotatercept for PAH in the STELLAR and ZENITH studies led to a loss of clinical equipoise in HYPERION.

Results from the Phase 3 LIBerate-HoFH trial found LDL-C responses generally similar between patients treated with lerodalcibep and evolocumab.

Awarded to Roche, the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay will be the first 510(k) cleared test measuring Lp(a) in nanomoles per liter (nmol/L).

Only 7% of patients presenting to US emergency departments received cardiac biomarker testing, with 2.8% diagnosed with ACS.

In this episode, Veeral Sheth, MD, is joined by the CEO of Orasis Pharmaceuticals to discuss Qlosi, a preservative-free, low-dose eye drop FDA-approved for presbyopia.

The regulatory agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 14, 2025.

Enobosarm led to a statistically significant benefit in the protection of lean mass in patients with overweight or obesity receiving semaglutide.

Medicaid-insured heart transplant recipients reported worse survival and higher risk of cardiac allograft vasculopathy over 5 years.

GLP-1 RA initiation boosted new thyroid cancer diagnoses, compared with other anti-diabetic drugs, but enhanced early detection may have played a role.

Subcutaneous amycretin achieved up to a 22.0% weight loss over 36 weeks, with a consistent safety profile to other incretin-based therapies.

Abelacimab achieved notably lower levels of free factor XI and fewer bleeding events than standard-of-care rivaroxaban in the Phase 2b trial.

Grade 2 or 3 cardiac uptake showed a 5-fold higher risk of cardiovascular death compared to grade 1 in asymptomatic ATTR cardiac amyloid infiltration.

Self-reported primary prevention aspirin use decreased among adults with both low and high ASCVD risk after the release of evidence-based guidelines.

Approximately 2.0% of commercially insured individuals with obesity, but not diabetes, initiated semaglutide within 6 months of diagnosis.