BioWorld MedTech

1 day ago | bioworld.com | Mark McCarty

FDA rapidly lists raft of class I device recallsThe U.S. FDA posted notice of six class I device recalls between June 3 and June 5, 2025, four of which are for corrections. BioWorld MedTech Regulatory U.S. CDRH FDA

1 day ago | bioworld.com | Coia Dulsat

Researchers from the University of Arizona have unveiled that coordinated Y chromosome loss in both cancer cells and immune cells may explain the worse prognosis in people with this alteration. The loss of the Y chromosome (LOY) is one of the most frequent somatic mutations in men, particularly with advancing age. More specifically, LOY shows increasing prevalence in circulating blood cells, affecting around 2.5% of 40-year-old men and up to 40% of 70-year-old men.

2 days ago | bioworld.com | Mari Serebrov

Regulatory, financial hurdles the gap between science and accessChildren with solid tumors who relapse are being treated with the same chemotherapy they would have been given 40 years ago, as “there have been no major approvals for pediatric solid tumors,” Catherine Bollard, senior vice president and chief research officer at Children’s National Hospital, said at a June 5 FDA roundtable on cell and gene therapies (CGTs). The problem isn’t the science.

2 days ago | bioworld.com | Tamra Sami

Ascletis’ denifanstat meets phase III endpoints in acne Ascletis Pharma Inc.’s once-daily oral fatty acid synthase inhibitor, denifanstat, demonstrated statistically significant and clinically meaningful improvements compared to placebo, meeting all primary and secondary endpoints in a phase III trial for moderate to severe acne vulgaris. BioWorld Clinical Dermatologic Small molecule Asia-Pacific China U.S.

2 days ago | bioworld.com | Nuala Moran

Home » EMA: New clinical guideline includes pregnant, breastfeeding patients BioWorld briefs for June 5, 2025. BioWorld MedTech briefs for June 4, 2025. The row between pharma companies and the U.K. government over rebates has intensified, with the Association of the British Pharmaceutical Industry calling up its... BioWorld Asia briefs for June 3, 2025 It’s a good week to be working on drugs targeting STAT6.