Drug Development
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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…