Recent regulatory and policy events continue to impact the biotech sector. The FDA has limited the use of bluebird bio's gene therapy Skysona due to increased cancer risk in clinical trial participants, underscoring safety concerns in gene therapies. Efforts to revive the Biosecure Act aim to address U.S.-China biotech engagement, reflecting ongoing geopolitical factors affecting the industry. Moreover, challenges persist regarding FDA decision-making processes, with concerns over transparency and expert panel deliberations highlighted by recent controversies.