CHMP Opinions September 2026
The CHMP (Committee for Medicinal Products for Human Use) is the EMA committee whose monthly opinions decide whether new medicines are recommended for approval in the EU. A positive opinion is normally followed by European Commission authorisation within ~67 days. Dates below come from official CHMP meeting agendas and highlights.
- CHMP opinion AMGN Amgen Inc. CHMP agenda item: Amgen Inc. — KANJINTI 2026-09-17
- CHMP opinion ARGX argenx SE CHMP agenda item: argenx SE — Vyvgart 2026-09-17
- CHMP opinion AZN AstraZeneca PLC CHMP agenda item: AstraZeneca PLC — Koselugo 2026-09-17
- CHMP opinion BAYN.DE Bayer AG CHMP agenda item: Bayer AG — BEYONTTRA 2026-09-17
- CHMP opinion BIIB Biogen Inc. CHMP agenda item: Biogen Inc. — Plegridy 2026-09-17
- CHMP opinion BNTX BioNTech SE CHMP agenda item: BioNTech SE — COMIRNATY 2026-09-17
- CHMP opinion FYB.DE Formycon AG CHMP agenda item: Formycon AG — Fymskina 2026-09-17
- CHMP opinion GALD.SW Galderma Group AG CHMP agenda item: Galderma Group AG — Nemluvio 2026-09-17
- CHMP opinion HNSA.ST Hansa Biopharma AB CHMP agenda item: Hansa Biopharma AB — Idefirix 2026-09-17
- CHMP opinion INCY Incyte Corporation CHMP positive opinion: Incyte Corporation — Povofortay 2026-09-17
- CHMP opinion MRNA Moderna, Inc. CHMP agenda item: Moderna, Inc. — mCOMBRIAX 2026-09-17
- CHMP opinion NOVN.SW Novartis AG CHMP positive opinion: Novartis AG — Cosentyx 2026-09-17
- CHMP opinion NOVN.SW Novartis AG CHMP agenda item: Novartis AG — EXJADE 2026-09-17
- CHMP opinion NOVO-B.CO Novo Nordisk A/S CHMP application withdrawn: Novo Nordisk A/S — Alhemo 2026-09-17
- CHMP opinion NOVO-B.CO Novo Nordisk A/S CHMP positive opinion: Novo Nordisk A/S — Frehemgo 2026-09-17
- CHMP opinion NOVO-B.CO Novo Nordisk A/S CHMP agenda item: Novo Nordisk A/S — Ozempic 2026-09-17
- CHMP opinion NOVO-B.CO Novo Nordisk A/S CHMP positive opinion: Novo Nordisk A/S — Sogroya 2026-09-17
- CHMP opinion ROG.SW Roche Holding AG CHMP agenda item: Roche Holding AG — Alecensa 2026-09-17
- CHMP opinion SNY Sanofi CHMP agenda item: Sanofi — Aldurazyme 2026-09-17
- CHMP opinion SNY Sanofi CHMP positive opinion: Sanofi — VaxRabeo 2026-09-17
- CHMP opinion SRRK Scholar Rock Holding Corporation CHMP application withdrawn: Scholar Rock Holding Corporation — Isembyld 2026-09-17
- CHMP opinion SRRK Scholar Rock Holding Corporation CHMP application withdrawn: Scholar Rock Holding Corporation — Isembyldt 2026-09-17
- CHMP opinion VRTX Vertex Pharmaceuticals Incorporated CHMP agenda item: Vertex Pharmaceuticals Incorporated — Casgevy 2026-09-17
- CHMP opinion VRTX Vertex Pharmaceuticals Incorporated CHMP application withdrawn: Vertex Pharmaceuticals Incorporated — Kaftrio 2026-09-17
- CHMP opinion VRTX Vertex Pharmaceuticals Incorporated CHMP application withdrawn: Vertex Pharmaceuticals Incorporated — Kalydeco 2026-09-17
- CHMP opinion VTRS Viatris Inc. CHMP agenda item: Viatris Inc. — Abiraterone Mylan, IBIRON 2026-09-17
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