# European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked

> **Newsylist Open Intelligence Dossier** · First detected: 2026-06-26 18:27 UTC · Category: Business · Sources: 8 · Current Velocity: 5.66

## Executive Summary
European regulators are recommending the revocation of marketing authorization for Amgen's rare-disease drug Tavneos following new data.

## Intelligence Brief
The Committee for Medicinal Products for Human Use (CHMP) has reversed its endorsement of Tavneos, a drug used for an autoimmune disease. European regulators are now recommending that the marketing authorization for the Amgen-developed treatment be revoked.


Coverage from Reuters, the Wall Street Journal, Endpoints News, and Fierce Pharma emphasizes the shift in the regulator's position. Medscape reports that the decision to revoke the drug's status was driven by new data.


Attention now turns to an upcoming FDA hearing regarding the drug, as noted in coverage from Fierce Pharma.

## Verified Facts & Key Claims
### What drug is facing authorization revocation?
The drug is Tavneos, developed by Amgen.

### Why is the authorization being revoked?
According to Medscape, the decision was prompted by new data.

### Which regulatory body issued the recommendation?
The recommendation was made by the CHMP (Committee for Medicinal Products for Human Use).

## Key People, Organizations & Locations
Decision, Tavneos, European Regulator Calls, Have Authorization Revoked, New Data Lead, Revoke Autoimmune Disease Drug, Europe's CHMP, Amgen FDA

## Multi-Source Evidence Table
| Source Outlet | Headline | Published (UTC) | Verification URL |
|---|---|---|---|
| FirstWord Pharma | Latest CHMP decisions led by recommendation to revoke approval of Tavneos | 2026-06-26 14:40 | [Source Link](https://news.google.com/rss/articles/CBMiU0FVX3lxTFBXRjdvUjJwdTZrSm8zdDY4c1ZKSlFCZWlhbS1Ub2xOQUpYY3laZEg5alJ1NDNNSW94UXVLSzdkYTROSElWODY2SnhZb0N4emtQcTJF?oc=5) |
| Citeline News & Insights | CSL Faces EU Withdrawal Of Tavneos After EMA Finds Study Data Unreliable | 2026-06-26 14:40 | [Source Link](https://news.google.com/rss/articles/CBMioAJBVV95cUxPbXFkVE02UkdRTloxMHBOa3JjZldLQVFGVUtSMERqSDdlcVgyNkUtMFBfQ3lKZWpySy1TUU9oam1na09Ca0ZmVGh1dzJIcllDa0tDWmNIZUJKV1R1dVl5bkFFNnVmNUd0V2d3YUdtMzVhSkpTYldjZk5kUmRVdmQ0eVhKZ25aMEpjNkRrU3U0dDNXUDZsN083cEFKa1ZscVVySUp1THNhZXF0MWJzbWJjbkdUdTdNeXZSYWFQblBVS3NieEg3SUFwajZqVlVjMmR5bGRMNERSZWEzbVFBSnVEM3JYVTRSNlMzU1JNU2hiZzZpMWhCc3BEQTNMYzhOWXNGTXllcGFCajV5VFRkODloRWI5ZFlxSW13bDRfUlZRVHg?oc=5) |
| Bloomberg | Inside FDA’s Effort to Pull an Amgen Drug Over Alleged Data Manipulation | 2026-06-26 14:40 | [Source Link](https://news.google.com/rss/articles/CBMitgFBVV95cUxPb2o4VGJRRnR5MTZMVXNGTEVaTk1kMGxYblNVX2ZYOUJzdWUxQVdkTmV1Yjd4YnpVNTVKYWtMbVlkaFdZMEFtZDg2ZG1la3B4S0dTRS1CNW5mQ3BBdkI1c0hHandlWmJmOGpWSDI1Vm1yZFJiakN5Y3dvckNiekZ5VjZERTZsckJJQVRiYUVyNWdXT2NaaUVYUHZoYkRkR0tTX3QxU1d3RUR1c1N3NU85RjFsYi05Zw?oc=5) |
| Medscape | New Data Lead to Decision to Revoke Autoimmune Disease Drug | 2026-06-26 14:40 | [Source Link](https://news.google.com/rss/articles/CBMipgFBVV95cUxNSndydlpUQXpoVXRPVlJ0aXpINFVXelRLUWJ0N0YxekNvX1dkSk1DSWpmcFZFSTl6VkZ2TVV6YXZFVk1ESlNvek9fOXBOTVBrczcxRTc1bjVPUWtuNUFIRnRPNjEyeEk4cTBldWRkMWtQOVVpN3FGSy0tMHNQLThEdlQ4NW1Ka3Itb0tMWGduSkVFQ3I5cHQwLU0wTVFzbTJwZU91T1VR?oc=5) |
| Fierce Pharma | Europe's CHMP reverses endorsement of Tavneos as Amgen FDA hearing looms | 2026-06-26 14:40 | [Source Link](https://news.google.com/rss/articles/CBMiqwFBVV95cUxQdEQxOUhsejdOLUFQMVBwbFAwRWh5Mjktbi1DcXZJWVBXNnV1anhYM2pFU21JaXFfenJueXF3bTNidDBFV3Z4aUJTbGZJWUdWT2I5bF9lQk9zN2tGaW9INDR1aGRCY3N4TU5MdDE2RkV0ZjBLSE9UWk81LWVKbHNwN2pJcVRfWnNvWXhJRnlOTGlzWm5Ec3B6UzA1bklEbmZ6amxsWTJzSnFhQkk?oc=5) |
| Endpoints News | EU regulators recommend revoking the marketing authorization for Amgen’s Tavneos | 2026-06-26 14:40 | [Source Link](https://news.google.com/rss/articles/CBMipgFBVV95cUxOWW11a3phWTJJT2NoQlVqRTh0b1hXd1N6eFI2WHYtSmdSLXpZSUc2TTU1UDdXbmdYR2NHa01acDB5WXBMd2FYWU50cTI1OXhxUUw3d2RfamVCMzVieWVXLWNZV2lxQ182WGp5VldXSkJkQWRHbldVeE9ycDR5Zy00SHNaZlF2b1kyYkVOaGtfWFRIQlp6YWxLeVpBVlRDaVJ2RTdaT2ln?oc=5) |
| Reuters | EU regulator backs revoking Amgen's right to sell rare-disease drug | 2026-06-26 14:40 | [Source Link](https://news.google.com/rss/articles/CBMi3AFBVV95cUxPQW1xek5kR0ljZzlCOUtEVnNfSWhSb2hVSVIxcTVGaWpoVllvaFF6VVhlNlRFNWtLWFFTc3lmcXpqZXZDOFk5UXFOZTdrTEdXS2diS0w0T21XWC1ZeVd1SUx2dXhTRU5HR1JGQUY3VTdKZlM5R2lzRFVDUl9KTVhmclRFSTV3aVU4MHBTd1BLZFRlM3NneUJkQTZXXzFmdm5rZFpfZmhUUkxpTWNiLVhOSVg5SkVqZ1RQSmNZSWY5YTI2TW5sX3NxOFk1bTU5TlpjZXhrUFI2TzRWZ2hE?oc=5) |
| WSJ | European Regulator Calls for Amgen’s Tavneos to Have Authorization Revoked | 2026-06-26 14:40 | [Source Link](https://news.google.com/rss/articles/CBMitwFBVV95cUxQVndPVFQ2SGVWbWlmVzVCNUpRQzhEclJhTmFFUXo4bFRLN3ZGejFEV3M0d1RqeXNGUEJ3N1NWcnBZV3hxdHl5dUYxbEFoM2JxeGs4OUpIYmNBYVJtcVpOQkpSWmhTWkUwN3JwX0RrOUhwVGMxcWl4aUFRVkR0RmtMOXVSMFVEWnh6VmF2TmtleE9SNEhpemN1d3k4TDdjdDlCcTFGQkZGc2V1YlFXN29kUWFZTDlPOFE?oc=5) |

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