The Centers for Medicare and Medicaid Services excused four drugs from being selected for Medicare price negotiation in the first round because they qualified for the small biotech exception, according to the agency.
‘Small Biotech Exception’ From Medicare Price Negotiation Granted To Four Drugs For 2026
CMS has not disclosed how many requests for the exception it received but will follow up with applicants regarding its decisions this month.

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Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
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