Regulatory Sourcebook

Final FDA guidance replaces 2011 potency testing advice, asking CGT makers to build potency assurance from IND filing through postmarket monitoring.

Teva will commercialize etanercept-ykro (Eticovo) and infliximab-abda, adding 2 TNF inhibitor biosimilars to US options for inflammatory diseases.

In the Phase 2a INFORM-MS trial, Tiziana’s nasal foralumab reduced microglial activation on PET imaging at 50 µg in non-active secondary progressive MS, while the 100-µg dose showed no significant effect.

The deal adds five US sites and about 1,100 employees, more than doubling Lonza’s US network and filling a gap in US bioconjugation capacity the company flagged weeks earlier.

CAR-T transformed blood cancer care, but solid and brain tumors demand different delivery, manufacturing, and safety strategies to work.

AAPS PharmSci 360 2026 in New Orleans centered on auditable AI, modeling-guided formulation, oral peptide delivery, high-concentration antibody suspensions, and the push toward $10-per-gram monoclonal antibodies.

Samsung Biologics' pending PolyPeptide deal adds peptide API manufacturing, including GLP-1 supply, to its antibody and ADC CDMO services.

The deal gives Fresenius options on biosimilars spanning monoclonal and bispecific antibodies, ADCs, and fusion proteins, starting with polatuzumab vedotin and teprotumumab, and could expand its portfolio from 29 to 66 molecules.