The FDA reaffirmed overall survival as the gold standard endpoint in cancer trials while embracing alternative measures in certain contexts. European approval of Bio-Thera’s Stelara biosimilar marks continued biosimilar market expansion amid private-label challenges from PBMs that may threaten biosimilar market viability. Meanwhile, MHRA pilots automatic approvals for clinical trial modifications, aiming to streamline research oversight. Additionally, emerging research highlights biosecurity risks from synthetic mirror microbes. Together, these developments underscore the dynamic regulatory landscape shaping biotech innovation and market competition.