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).

Base drug cards and JSON also expose compact approval fields derived from the existing normalized approval date:

• approval_date_raw keeps the stable ISO form,
• approval_date_display provides a human-friendly month-name rendering,
• approval_summary provides a one-line "FDA approved on <date>" summary.

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