FDA drops blood pressure device enforcement against Whoop
The FDA has sent an End of Enforcement notice to consumer wearable device company Whoop, putting a formal end to the Agency’s investigation into its blood pressure tech use.
The FDA has sent an End of Enforcement notice to consumer wearable device company Whoop, putting a formal end to the Agency’s investigation into its blood pressure tech use.
Adhering to Quality by Design (QbD) principles and employing risk-based monitoring strategies should reduce the likelihood of Clinical Investigators or Sponsors receiving a Form FDA-483, Inspectional Observations, following a Bioresearch Monitoring (BIMO) inspection.
Mice with DMD (Duchenne Muscular Dystrophy) regain muscle function after targeted mRNA treatment: Engineered extracellular vesicles delivered full-length dystrophin mRNA to skeletal muscle of mice with Duchenne Muscular Dystrophy (DMD), restoring dystrophin production and improving muscle strength and function, according to a study in Nature Biomedical Engineering. Safety testing with non-human primates found the treatment was well tolerated, supporting its potential as a non-viral alternative to current gene therapies.
The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two (2) years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024.
Twenty-six years of chasing New York City sex crimes as the face of “Law & Order: Special Victims Unit (SVU)” has prepared award-winning actress Mariska Hargitay to put on her own detective hat in her next role: “Investigating Myeloma” with Bristol Myers Squibb.
On 09 JUN 2026, the U.S. Food and Drug Administration (FDA) added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the Agency’s efforts to advance sunscreen innovation. Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.
Police Tussle With Diabetes Experts at ADA Meeting — Researchers told they could no longer attend the annual scientific sessions”: On 05 JUN 2026, several diabetes researchers were brusquely escorted out of a major scientific conference organized by the American Diabetes Association (ADA), for distributing paper copies of an editorial criticizing the Trump administration. In the days since, video of the incident has rocketed around social media, stoking widespread backlash from the scientists against the ADA.
Philanthropist Melinda French Gates is donating $215 million to improve women’s health globally, saying that women’s health is “fundamental.” She has donated more than $600 million to women’s health in the past two (2) years and hopes this latest round of funding will encourage other donors and governments to increase support for women’s health.
Government Taps Radiological Waste to Strengthen U.S. Access to New Cancer-fighting Therapies: The scalable, cost-effective model helps secure a domestic supply of scarce medical radioisotope feedstocks while reducing legacy radiological waste.
An experimental drug developed by GSK functionally cured 19% of patients with hepatitis B in two Phase 3 trials published in The New England Journal of Medicine. The drug, bepirovirsen, targets HBV messenger RNA to block viral protein production, promote destruction of the virus, and stimulate immune responses. The company has submitted the data to Regulators in the United States, Europe, Canada, Japan, and China.