The U.S. Food and Drug Administration has approved Yeztugo (lenacapavir), a powerful new HIV-prevention drug developed by Gilead Sciences. Given via injection just twice a year, Yeztugo has shown remarkable success in clinical trials, virtually eliminating HIV transmission among recipients. It significantly outperformed existing daily oral PrEP drugs like Truvada, cutting infection rates by 89% among gay and bisexual men and transgender individuals. In a separate trial among cisgender women in sub-Saharan Africa, none of the participants who received Yeztugo contracted HIV.
On June 12, 2025, the FDA approved pembrolizumab (Keytruda) as a new treatment option for adults with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) that shows PD-L1 expression with a combined positive score (CPS) of 1 or higher. This approval introduces a new approach to treating head and neck cancer that begins before surgery and continues afterward.
The research investigated the association of the Neutrophil Percentage-to-Albumin Ratio (NPAR) with mortality risk in diabetes or prediabetes patients. NPAR is a metric that reflects both inflammation, as presented in neutrophils, and nutrition, as presented in albumin. The researchers had 6,080 American adults with diabetes or prediabetes data, obtained between 2001 and 2018, via the National Health and Nutrition Examination Survey (NHANES). The population was followed up for a total of 53,217 person-years over which 1,378 deaths occurred, 476 from cardiovascular disease.
The FDA has provided traditional approval to pembrolizumab (Keytruda) plus trastuzumab, fluoropyrimidine-, and platinum-based chemotherapy for the initiation of treatment in adult patients with HER2-positive gastric or GEJ adenocarcinoma with PD-L1 expression (CPS ≥ 1). It was previously approved in May 2021, under accelerated approval, on the basis of interim results from the KEYNOTE-811 trial.
The FDA implemented a significant change to make clozapine, the only prescription drug for treatment-resistant schizophrenia, more widely available. Patients once had to undergo frequent blood tests before they could have their prescriptions filled because of a potentially lethal but rare side effect, neutropenia, which decreases white blood cell levels and compromises the immune system. But after years of complaint from doctors, pharmacists, and families, the FDA eliminated this requirement.
Medtronic received FDA approval for its BrainSense Adaptive Deep Brain Stimulation (aDBS) system and the BrainSense Electrode Identifier (EI) to treat patients with Parkinson’s disease. This technology represents a major step forward in treatment by allowing the device to adapt stimulation automatically in real-time based on the neural activity of the patient.
