FDA Watch: Upcoming Decisions for Dynavax, Ascendis, and BMS Therapies


The FDA has several important decisions to make in the next three weeks, with four key deadlines approaching. Among these are the potential approvals of a novel CAR-T therapy and a hepatitis B vaccine.

Bristol Myers Squibb is awaiting the FDA’s verdict on their CAR-T therapy, which targets the B-cell maturation antigen (BCMA) and could provide a new treatment option for patients with multiple myeloma. The agency is also considering Dynavax Technologies’ hepatitis B vaccine, designed to offer protection against the viral infection with fewer doses than currently available vaccines.

Additionally, Ascendis Pharma is anticipating a decision on their long-acting growth hormone treatment for pediatric patients with growth hormone deficiency. The FDA’s upcoming actions could potentially bring new therapeutic options to patients in need and shape the future of these biotech companies.