Regulatory and Standard Setting Organizations

This FAQ explains how aseptic processing, contamination control, and validation protect patients amid sterile injectable failures.

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

Johnson & Johnson's amivantamab (Rybrevant Faspro) won accelerated FDA approval for pretreated recurrent head and neck cancer.

FDA’s draft framework would let sponsors add patient-specific genome editing variants to an approved BLA using in vitro data. Here is what the guidance proposes, what evidence it asks for, and what remains unresolved.

Akeso won NMPA priority review for ivonescimab plus chemotherapy in first-line biliary tract cancer after a phase 3 win over durvalumab plus chemo.

VG801 gene therapy improved vision through 12 months in a Stargardt disease trial as VeonGen aligned with FDA on its pivotal phase 3 design.

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