FDA Documents Online

Shilpa CDMO's $50 million plan adds 10 kL of SPPS reactor capacity in Raichur, India, with its first commercial peptide line opening in December 2026.

Today’s BioPharm Brief covers FDA’s final potency assurance guidance for cell and gene therapies, Lonza’s deal to acquire Merck KGaA’s US CDMO business, and Phase 2a data for Tiziana’s intranasal anti-CD3 antibody foralumab in progressive multiple sclerosis.

At AAPS PharmSci 360 2026, University of Iowa PhD candidate Siddhanth Hejmady explains how adding a payload or radiolabel to trastuzumab changes its behavior in bulk solution and at interfaces, and why developability teams should pair DLS with QCM-D.

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.