FDA Approves Perioperative Pembrolizumab for Head and Neck Cancer Based on KEYNOTE-689 Trial

FDA Approves Perioperative Pembrolizumab for Head and Neck Cancer Based on KEYNOTE-689 Trial

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.

FDA Approves First-Ever Drug for Hunger in Prader-Willi Syndrome

FDA Approves First-Ever Drug for Hunger in Prader-Willi Syndrome

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.

Pembrolizumab Gains FDA Approval for Advanced HER2+ Gastric Cancer Treatment

Pembrolizumab Gains FDA Approval for Advanced HER2+ Gastric Cancer Treatment

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.

New FDA Rule Boosts Access to Life-Changing Schizophrenia Drug

New FDA Rule Boosts Access to Life-Changing Schizophrenia Drug

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.

FDA Greenlights Real-Time Adaptive DBS to Improve Parkinson’s Treatment

FDA Greenlights Real-Time Adaptive DBS to Improve Parkinson’s Treatment

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.

FDA Greenlights New Meningococcal Vaccine for Broader Protection

FDA Greenlights New Meningococcal Vaccine for Broader Protection

The study introduces a novel method of acknowledging the important connection between a pregnant woman’s peri- and post-natal mental health and cardiac health. Doctors in the past have most frequently taken into account body functions like blood pressure and cholesterol when measuring a woman’s cardiovascular health.