The FDA approved Boehringer Ingelheim’s oral HER2-targeted drug Hernexeos for non-small-cell lung cancer, accompanied by clearance of Oncomine Dx Target Test as its companion diagnostic. Meanwhile, Vinay Prasad returned as director of the FDA's CBER division after a brief hiatus. President Trump issued an executive order centralizing federal grantmaking decisions and increasing political oversight of research funding distributions. These regulatory actions and leadership changes are influencing industry operations and investor sentiment.