JANSSEN CILAG

Predicine has submitted the first module of a premarket approval application to the FDA for PredicineCARE, a urine cell-free DNA next-generation sequencing assay for use as a companion diagnostic in bladder cancer.

RedHill Biopharma received positive FDA feedback for the first-ever clinical study targeting Mycobacterium avium subspecies paratuberculosis (MAP) infected Crohn's disease patients with RHB-204.

Synendos Therapeutics has appointed Dr. George Garibaldi as Chief Medical Officer as the company transitions from Phase 1 to Phase 2 clinical development of its lead drug candidate SYT-510.

The STAMPEDE trial found that adding metformin to standard care for 1,874 non-diabetic men with metastatic prostate cancer did not significantly improve overall survival (HR 0.91, 95% CI: 0.80-1.03, P = 0.15).

The FDA is revising labeling for all extended-release ADHD stimulants to include warnings about weight loss and adverse reactions in children under six years old.

The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for USYMRO (ustekinumab), Bio-Thera Solutions' biosimilar referencing Stelara.

Johnson & Johnson's investigational menin inhibitor bleximenib demonstrated an 82% overall response rate in relapsed/refractory AML patients when combined with venetoclax and azacitidine in Phase 1b trials.

Biocytogen Pharmaceuticals has received a Japan Patent Office invention patent for its RenMab fully human antibody mouse platform technology, marking a significant milestone in global intellectual property expansion.

A two-year investigation found that 73% of the 429 drugs approved by the FDA from 2013-2022 failed to meet the agency's four foundational standards for proving effectiveness.

A large population-based study of 10,182 childhood cancer survivors found they face a five-fold higher risk of developing chronic kidney disease and hypertension compared to the general pediatric population.