FDA approves Italian non-profit Fondazione Telethons BLA for Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome.
Childrens Health Defense asks FDA to revoke BLA approvals for all Pfizer and Moderna mRNA Covid-19 vaccines, claiming they do not comply with BLA requ...
FDA warns Brookhaven, GA-based Ponya Therapeutics about violations of regulations governing human cells, tissues, and cellular and tissue-based produc...
FDA clears a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improve attention in adults with attention-deficit/hyper...
Roche reports positive Phase 3 lidERA trial results for its giredestrant selective estrogen receptor degrader endocrine therapy in some breast cancer ...
Reuters reports that Daniel McMullen, the former director of the CDRH Office of Neurological and Physical Medicine Devices, has joined Elon Musks Neur...
CBER officials pen a new JAMA article signaling a major policy shift for cancer CAR T-cell therapies, moving away from reliance on single-arm studies ...
Four Hogan Lovells attorneys describe a potential significant shift in Justice Department enforcement boundaries, especially involving off-label presc...
