How often does the FDA approve new cancer drugs?

The FDA Oncology Center of Excellence typically grants 40-60 new oncology approvals per year, including new molecular entities and supplemental approvals for expanded indications. This tracker updates daily from the official FDA press release feed.

What is the difference between an FDA new approval and a label expansion?

A new approval (also called a new molecular entity or NME) is the first FDA authorization for a drug. A label expansion is a supplemental new drug application (sNDA) or biologics license application (sBLA) that adds a new indication, population, or combination to an already-approved drug.

What is FDA accelerated approval in oncology?

FDA accelerated approval allows drugs to be approved based on a surrogate endpoint (such as response rate or progression-free survival) that is reasonably likely to predict clinical benefit. Drugs approved under this pathway must complete confirmatory trials demonstrating overall survival or other direct clinical benefit.

Where can I find EMA oncology approvals?

The European Medicines Agency (EMA) publishes European Public Assessment Reports (EPARs) for all approved medicines. The EMA CHMP (Committee for Medicinal Products for Human Use) meets monthly and publishes opinions on new oncology drug applications. This page aggregates recent EMA oncology approvals alongside FDA notices.

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FDA & EMA Regulatory News

Real-time oncology approval tracker. New drug approvals, supplemental label expansions, and regulatory decisions from the FDA Oncology Center of Excellence and European Medicines Agency — sourced directly from official feeds.

Sources: FDA Hematology/Oncology EMA EPAR Database NCI Press Releases

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Approval Types

New Approval First indication for drug

Expansion Additional indication added

Accelerated Contingent on confirmatory trial

Withdrawal Indication voluntarily withdrawn