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.

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 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.

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

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 ...

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

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 FDA granted a Commissioner's National Priority Voucher to accelerate the review of the treatment, which was submitted for approval last month.

The firm will focus on encouraging physicians to prescribe the combination therapy for ovarian cancer patients at first recurrence.

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