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FDA new drug approvals in Q1 2022

  1. Lisa Urquhart

    1. Evaluate Vantage, London, UK.

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With the first quarter of 2022 now in the rear-view mirror, the FDA has approved 10 new drugs (Table 1), 4 short of the total this time last year. The decline might add fuel to speculation that the agency is showing more rigour around authorizations following the controversy surrounding Alzheimer’s drug Aduhelm (aducanumab). But despite what looks like a rise in complete response letters, many for manufacturing issues, it is too early in the year to give a clear steer in which direction the agency might be going under the leadership of newly elected commissioner Robert Califf.

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Nature Reviews Drug Discovery 21, 329 (2022)

doi: https://doi.org/10.1038/d41573-022-00063-9

Updates & Corrections

  • Correction 20 April 2022: Suvorexant and and lemborexant were described as orexin receptor agonists rather than antagonists, and this has been corrected.

Competing Interests

The author declares no competing interests.

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