The Food and Drug Administration (FDA) is undergoing significant operational and decision-making changes affecting the biotech industry. Internally, employees have expressed concerns about staffing and the use of informal expert meetings lacking transparency. These unconventional panels bypass standard advisory committee protocols, as exemplified by the rejection of Replimune’s RP1 therapy despite internal support. Furthermore, the FDA is restricting bluebird bio's gene therapy Skysona due to rising cancer diagnoses among trial participants. Meanwhile, the FDA continues to approve innovative therapies, such as Boehringer Ingelheim’s lung cancer pill zongertinib and the embrace hydrogel embolic system by Instylla. Public trust in the FDA’s decision-making process remains a critical issue amid these developments.