Documentary record · October 19, 2026 edition
EMA's CHMP recommends six new medicines, including oral orforglipron
CHMP POSITIVE OPINION — COMMISSION DECISION PENDING
SOURCE-VERIFIED · HUMAN REVIEW PENDING
Event date
CHMP meeting October 12–15, 2026
Authority
EMA Committee for Medicinal Products for Human Use
Lifecycle state
CHMP POSITIVE OPINION — COMMISSION DECISION PENDING
Source published
October 16, 2026
Source checked
October 20, 2026
Published on KPSGILL
- Foundayo (orforglipron): once-daily oral GLP-1 receptor agonist for weight management and type 2 diabetes in adults. (FDA-approved in the U.S. for chronic weight management, April 1, 2026.)
- Rasonque (daraxonrasib): metastatic pancreatic adenocarcinoma after at least one prior treatment. It was a high-priority medicine under EMA's Cancer Medicines Pathfinder, reviewed in phases.
- Yuviwel (navepegritide): achondroplasia in children.
- Also: two biosimilars; Kizfizo (temozolomide, hybrid application); five extensions of indication (H5N1 pandemic vaccine AstraZeneca, Kyinsu, Talvey, Tryngolza, Tukysa); and a recommended switch of Nyxoid (naloxone nasal spray) to non-prescription status.
Does not establish
EU marketing authorisation. Each product transitions only when the European Commission decides.
Sources
- EMA CHMP 12-15 Oct 2026 highlights Primary · 2026-10-16 · checked 2026-10-19
- FDA Novel Drug Approvals 2026 (Foundayo orforglipron approved 2026-04-01) Primary · 2026-04-01 · checked 2026-10-20
Related on this site
Register: the record store · record id ema-chmp-october-2026-opinions-2026-10-15 · SOURCE-VERIFIED · HUMAN REVIEW PENDING.