The former commissioner pushed a regulatory pathway for rare disease drugs and launched a voucher program for expedited ...

The firm will report more data on the CAR T-cell therapy's durable efficacy later in the year and anticipates completing regulatory submissions in the fourth quarter.

The firm will be in charge of commercializing the drug in the US, where it was approved this month for treating ER-positive, HER2-negative, ESR1-mutant advanced breast cancers.

NEW YORK – Fractyl Health said Monday that it would be launching a Phase I/II trial of its investigational gene therapy for type 2 diabetes, RJVA-001, in the second half of this year. The ...

NEW YORK – Curocell and ProBio, which provides cell therapy manufacturing support to biotechs, say they're one step closer to treating lymphoma patients in South Korea with the autologous ...

The regulatory body wants public feedback on whether the definition should be updated to comprise biological and synthetic products.

The firm is evaluating the combination in a Phase I trial to determine if it improves responses and reduces acquired resistance.

Institutions' precision medicine programs are maturing, facing new questions about how AI will change clinical decision ...

The agency's acceptance was based on results from the Phase III OptiTROP-Lung05 study, which met its primary endpoint of progression-free survival.

The company looked externally for cell therapy and ADC additions to its pipeline last quarter, keeping internal R&D spending ...

The firm's lead program is an in vivo CAR T-cell therapy it's developing with its mRNA platform for B-cell mediated autoimmune diseases.