Single-Use Technology for Syringe Filling

FDA's consumer safety officer, Jason Chancey, detailed real inspection findings, such as taped gaskets and delayed retesting, behind sterile facility deficiencies.

Guselkumab eased spinal pain, stiffness, and MRI-confirmed spinal inflammation in a 411-patient trial of psoriatic arthritis with axial involvement.

Dr Stephen Wilson, CEO of the Botnar Institute of Immune Engineering, describes Basel's collaborative ecosystem and a 3-year roadmap linking research to global clinical partners.

BIIE CEO Dr Stephen Wilson outlines rapid growth plans and a multidisciplinary technology stack targeting global clinical translation.

Dazodalibep hit its phase 3 primary endpoint at week 48, building on phase 2 data showing a 6.3-point ESSDAI reduction versus placebo.

Made Scientific's new 85,000-sq.-ft. facility, with 145 prior GMP batches, adds clinical- to commercial-scale cell therapy capacity.

Novo Nordisk reports that CagriSema outperformed tirzepatide with 12.4% weight loss versus 9.1% in a phase 3 trial in adults with type 2 diabetes.

Vironexis Biotherapeutics reported that the first three antibody-naive patients with relapsed/refractory acute lymphoblastic leukemia treated with its one-time in vivo immunotherapy VNX-101 all achieved MRD-negative complete responses, with durability tracked through at least nine months.