The FDA has issued an early alert involving Abiomed Automated Impella Controllers after purge-cassette recognition failures were associated with 37 serious injuries and three deaths, prompting replacement of controller components used with life-sustaining heart pumps.
Milvexian failed to reduce cardiovascular death, heart attack or ischemic stroke after acute coronary syndrome in the Phase 3 LIBREXIA ACS trial, although the drug did not increase intracranial or fatal bleeding, leaving two major Phase 3 programs to determine whether factor XIa inhibition still works in other diseases.
Johnson & Johnson has secured FDA approval for IMAAVY in warm autoimmune hemolytic anemia, giving eligible patients aged 12 and older the first treatment specifically approved in the United States for wAIHA.
Europe has approved teclistamab plus daratumumab after MajesTEC-3 showed an 83.4% reduction in progression or death and a significant overall-survival advantage versus established regimens.
MONARCH QUEST 3 adds AI nodule segmentation, improved registration, 3D orientation and broader cone-beam CT integration as Johnson & Johnson targets more reliable lung nodule navigation.
EU approval moves TECVAYLI plus daratumumab into earlier multiple myeloma treatment after Phase 3 data cut progression risk by 83.4%.
Johnson & Johnson has received FDA De Novo authorization for the OTTAVA robotic surgical system across multiple upper-abdominal procedures. Its table-integrated design could bring robotic surgery into smaller operating rooms, but clinical evidence, surgeon training and hospital economics will determine whether it can challenge Intuitive Surgical.
Johnson & Johnson closes its $1 billion Firefly Bio deal, adding a preclinical degrader antibody conjugate platform for KRAS-driven cancers.
Johnson & Johnson backs Sail Biomedicines’ in vivo CAR-T platform with $785 million in initial payments and a $2.58 billion buyout option.
Johnson & Johnson proposes a $5.5 billion deal for 76,000 ovarian talc claims, but participation, future lawsuits and costs remain critical.