BioWorld

BioWorld Today provides valuable insights into groundbreaking drug development that fuels the healthcare industry and helps combat diseases. With a team of writers and editors located worldwide, BioWorld Today covers the latest news and offers essential viewpoints on numerous medicines in the pipeline, the companies developing these treatments, the business deals shaping the industry, and the regulatory challenges that both hinder and protect the process.

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Articles

FDA rapidly lists raft of class I device recalls

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
Loss of Y chromosome in cancer, immune cells: a new clue to cancer outcomes

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.
Regulatory, financial hurdles the gap between science and access

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.
Ascletis’ denifanstat meets phase III endpoints in acne

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.
EMA: New clinical guideline includes pregnant, breastfeeding patients

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.
FDA’s device center playing guidance catch-up

2 days ago | bioworld.com | Mark McCarty

FDA’s device center playing guidance catch-upThe U.S. FDA’s Center for Devices and Radiological Health is recovering from a guidance drought that spanned several months in the first part of calendar year 2025, starting with a guidance on the Q-sub process. BioWorld MedTech Regulatory Gynecology/obstetrics U.S. FDA
Epigenetics tells the story of aging blood cells

2 days ago | bioworld.com | Mar De Miguel

Home » Epigenetics tells the story of aging blood cells BioWorld briefs for June 4, 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. Kymera Therapeutics Inc.’s, KT-621, the first oral STAT6 degrader candidate to enter the clinic,...
Loss of Y chromosome in cancer, immune cells: a new clue to cancer outcomes

2 days ago | bioworld.com | Coia Dulsat

CancerLoss of Y chromosome in cancer, immune cells: a new clue to cancer outcomesResearchers 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.
Loss of Y chromosome in cancer, immune cells: a new clue to cancer outcomes

2 days ago | bioworld.com | Coia Dulsat

CancerLoss of Y chromosome in cancer, immune cells: a new clue to cancer outcomesResearchers 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 is one of the most frequent somatic mutations in men, particularly with advancing age. BioWorld MedTech Cancer
Telemedicine at the root of false claims conviction for more than $1B

3 days ago | bioworld.com | Mark McCarty

Telemedicine at the root of false claims conviction for more than $1BU.S. Medicare coverage of telehealth and telemedicine sometimes seems to lag inappropriately, but fears of fraud were borne out in a conviction obtained recently by the Department of Justice. BioWorld MedTech Regulatory U.S.