FDA Final Rule

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.

FDA set a May 1, 2027 target date for AMT-130, a one-time gene therapy that silences the huntingtin gene, and plans an advisory committee meeting.

Inovio reports that Voceryq spared 27% of adults with recurrent respiratory papillomatosis from surgery for 12 months in a 26-patient efficacy group.

Three case studies show how automated Raman plate reading can triage samples before chromatography in bioprocess development.

This year’s AAPS PharmSci 360 highlighted AI transparency, computer modeling in formulation, oral peptide delivery, and new business models.