FDA Clinical Trials
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What Is an IND Application? How Drugs Enter Human Clinical Testing
Before a drug can be tested in a single human patient, the company developing it must file an Investigational New Drug application — commonly called an IND — with the FDA. The IND is the regulatory gateway to clinical trials. Without it, no Phase 1, Phase 2, or Phase 3 study can legally begin in…
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What Is Breakthrough Therapy Designation? FDA’s Accelerated Path Explained
When the FDA grants a biotech company Breakthrough Therapy Designation for a drug, the market typically reacts immediately — and often positively. The designation is a signal from one of the world’s most respected regulatory agencies that a drug shows early evidence of substantial improvement over existing therapies for a serious condition. For investors in…
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What Is a PDUFA Date? The FDA Milestone Every Biotech Investor Should Know
The PDUFA date is one of the most closely watched events on any biotech investor’s calendar. When the FDA sets one for a drug under review, it marks the day the agency has committed to issuing a decision — and the entire market pays attention. A stock can move 30%, 50%, or more in a…