Ciltacabtagene autoleucel (cilta-cel; Carvykti) for multiple myeloma has a new boxed warning for immune effector cell-associated enterocolitis (IEC-EC), the FDA announced on Friday.

CAR2119’s single-infusion approach offers cost and compliance advantages, though its competitors maintain strong commercial ...

The FDA adds a new boxed warning for immune effector cell-associated enterocolitis with Carvykti, but says the overall ...

Autoimmune rheumatic diseases (ARDs), such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and systemic ...

Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now. The FDA has removed the Risk Evaluation and ...

In a matched analysis involving 110 patients with transformed indolent non-Hodgkin lymphoma (TriNHL) and 391 patients with de ...