The US Food and Drug Administration (FDA) is considering a potential major change in its approval process, with the Commissioner's office planning to be more involved in many drug approvals. This development comes amid reports that the FDA Commissioner has rejected some proposed reorganization plans. Despite these internal changes and some norms being overlooked, the biotech sector has shown resilience, with the iShares Biotechnology ETF (ticker: IBB) and other small-cap biotech stocks experiencing positive momentum. Recent strong drug launches by companies such as BridgeBio Pharma (BBIO), Madrigal Pharmaceuticals (MDGL), and Verona Pharma (VRNA) have contributed to this optimism. Additionally, mergers and acquisitions activity is picking up in the biotech space, although the landscape remains complex. Industry observers note that drugmakers should not be overly concerned about FDA delays at this stage. The biotech ETF XBI has shown steady gains, reflecting a positive mood in the sector, while Regeneron Pharmaceuticals (RGNX) recently surpassed $10 per share for the first time in a while.