Pharmaceuticals
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What Is Combination Therapy? Why Biotech Companies Pair Drugs Together
Look at the treatment regimen for almost any serious chronic or complex disease — HIV, tuberculosis, most advanced cancers, hepatitis C before it was cured — and you will find combination therapy: two or more drugs used together rather than a single agent alone. Combination therapy is one of the most consistently successful strategies in…
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What Is Off-Label Drug Use? The Practice Every Biotech Investor Should Understand
When the FDA approves a drug, it approves it for a specific indication — a defined patient population with a defined disease or condition. But once a drug is on the market, physicians are legally permitted to prescribe it for any use they believe is in their patient’s best interest, including uses not mentioned on…
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What Is Drug Repurposing? Finding New Uses for Existing Drugs and Why It Matters to Investors
Some of the most significant drug approvals of the past decade came not from entirely new molecules, but from existing drugs — already approved, already manufactured, already understood — that were found to work in entirely new diseases. Drug repurposing, also called drug repositioning, is the systematic effort to find new therapeutic applications for compounds…
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What Is a Drug’s Mechanism of Action? A Plain English Guide for Biotech Investors
Every biotech press release describing a drug in clinical development includes at least a brief description of the drug’s mechanism of action. Yet for many retail investors, this section gets skimmed — it reads like jargon, and the significance of the underlying science is not always obvious. Understanding what mechanism of action means, why it…
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What Is the Difference Between an NDA and a BLA? The Two Paths to FDA Drug Approval
When a biotech or pharmaceutical company completes its clinical trial program and is ready to ask the FDA for approval, it faces a fundamental fork in the road: file a New Drug Application (NDA) or file a Biologics License Application (BLA). The correct choice is not a matter of preference — it is determined entirely…
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How Does the FDA Drug Approval Process Work? A Complete Guide for Investors
The path from a molecule in a laboratory to an FDA-approved drug available to patients is one of the most complex, expensive, and high-stakes journeys in modern science. On average, it takes 10 to 15 years and costs more than $1 billion — and even then, fewer than 1 in 10 drugs that enter clinical…
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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…