Managing Quality in Single-Use Systems

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

Advanced modeling provides greater understanding for more-informed decision making across all phases of drug development.

Linvoseltamab-gcpt, marketed as Lynozyfic, is a bispecific antibody designed to facilitate T cell activation and cancer cell killing.

EDQM is providing the 12th edition of the European Pharmacopoeia as an all-digital, redesigned, user-friendly issue.

The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).

Some of the companies that received American samples, FDA said, are partially owned or controlled by the Communist Party in China.