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Drug Approvals and Adverse-Event Summary

This reference covers the new Drugs@FDA approvals section and FAERS summary statistics.

Drug approvals (Drugs@FDA)

Use the approvals section on drug entities:

biomcp get drug dabrafenib approvals

The section includes:

  • application number (NDA/BLA),
  • sponsor,
  • key product rows (brand/dosage form/route/status),
  • submission timeline rows (type/number/status/date).

FAERS summary statistics

FAERS search responses include summary metadata above the report table:

biomcp search adverse-event -d pembrolizumab --limit 10

Summary fields:

  • total reports from OpenFDA metadata,
  • returned report count,
  • top reactions with count and percentage.

The same summary appears in:

biomcp drug adverse-events pembrolizumab --limit 10