Why Biotech Just Had Its Best Week in Years—And Why This Rally Could Be Different

Two major FDA policy shifts are rewriting the rules for drug approvals, sending biotech stocks soaring to 52-week highs

If you've been watching the biotech sector lately, you've probably noticed something unusual: it's actually going up. After years of volatility and regulatory headaches, biotech stocks are suddenly red-hot, with major ETFs hitting 52-week highs and investors piling back into a sector many had written off.

But here's the thing—this isn't just another flash-in-the-pan rally. What happened in mid-November 2025 represents a fundamental shift in how the FDA operates, and smart investors are starting to understand the implications.