June 2nd 2025
In the DESTINY-Breast09 study, Enhertu (fam-trastuzumab deruxtecan-nxki) plus pertuzumab reduced the risk of disease progression or death by 44% in patients with HER2-positive metastatic breast cancer.
Roche’s Susvimo Lands FDA Approval for Diabetic Retinopathy Based on Phase III Pavilion Trial Data
May 22nd 2025One-year results from the Pavilion study showed patients who received Susvimo (ranibizumab) refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale.
Data from the FIBRONEER-IPF and FIBRONEER-ILD studies, published in The New England Journal of Medicine, highlight nerandomilast’s potential as a first-in-class PDE4B inhibitor for idiopathic and progressive pulmonary fibrosis, demonstrating efficacy as monotherapy or with existing antifibrotics.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.
The global, randomized IDeate-Esophageal01 study will evaluate ifinatamab deruxtecan, a B7-H3–targeted antibody-drug conjugate, versus physician’s choice of chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma following progression on platinum-based chemotherapy and immune checkpoint inhibitors.
Oveporexton Shows Superior Efficacy in Phase II Narcolepsy Type 1 Trial Without Hepatotoxicity
In the TAK-861-2001 Phase IIb study, oveporexton significantly improved wakefulness, daytime sleepiness, and cataplexy frequency in patients with narcolepsy type 1, outperforming current therapies and avoiding liver toxicity seen with earlier OX2R agonists, according to results published in The New England Journal of Medicine.