Home Investing Strategy Portfolio Strategy Summary Recent FDA decisions, including the rejection of Replimune's RP1 and approval of Iovance's Amtagvi, highlight the agency's controversial and high-stakes role in biotech outcomes. Leadership turmoil at the FDA, with Commissioner Dr. Makary reportedly at risk of dismissal, reflects mounting political and media scrutiny over drug approval processes. High-profile drug rejections and approvals—such as those for UniQure, Atara, Regenxbio, Sarepta, Biogen and Amylyx—underscore the complexity and unpredictability of regulatory outcomes. Investors are advised to expect volatility in biotech, with diversified ETF exposure (IBB, XBI, BBH) offering insulation from single-stock swings driven by regulatory events. Looking for more investing ideas like this one? Get them exclusively at Haggerston BioHealth.…