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Adagrasib · Regulatory label update
U.S. Food and Drug Administration · March 25, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA issued a supplemental approval (labeling change) for adagrasib (Krazati, 200 mg oral tablet) on 25 March 2026. This is an administrative action that updated product labeling; the record does not contain clinical trial results, efficacy data, or safety findings.
Regulatory label update.
The FDA issued a supplemental approval (labeling change) for adagrasib (Krazati, 200 mg oral tablet) on 25 March 2026. This is an administrative action that updated product labeling; the record does not contain clinical trial results, efficacy data, or safety findings.
This record documents a labeling supplement only; it does not contain clinical trial results, efficacy data, safety findings, or comparative benefit information.
The source did not state who this applies to in practice.
This is an FDA supplemental approval action for a labeling change to adagrasib; it documents an administrative decision, not clinical efficacy or safety data.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Drugs@FDA record for application NDA216340. This is a regulatory action record, not a clinical study. Brand name: KRAZATI. Active ingredient: ADAGRASIB. Sponsor: BRISTOL. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-03-25. Products: KRAZATI, TABLET, ORAL, ADAGRASIB 200MG.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.