FDA leadership has generally seemed apprehensive of going too hard on companies that don’t meet clinical trial diversity goals, but some industry insiders say a stronger FDA is needed to spark real change. Delayed guidance could indicate if the agency will change course.

The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.

As COVID-19 vaccine sales decline, the company is investing billions in a diverse oncology pipeline including antibody drug conjugates, immunotherapy and cancer vaccines

Advances in synthetic biology are moving biopharma closer to a world where treatments can be tailored while remaining cost-effective.