#marketingauthorisation — Public Fediverse posts

What Ojemda’s JCA reveals about new era of clinical HTA in Europe

The first published joint clinical assessment (JCA) hands the innovative pharmaceutical industry a working template for a process…
#Europe #EU #BRAF #clinicalassessment #EUmemberstate #European #HTA #HTAdatabase #JCA #marketingauthorisation #relativeeffectiveness #safetyevaluation
https://www.europesays.com/europe/98509/

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

ST. GALLEN, Switzerland, June 26, 2026 /PRNewswire/ — Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL announced…
#Europe #EU #EuropeanCommission #ChemoCentryx #EuropeanMedicinesAgency #EuropeanUnion #FreseniusMedicalCare #granulomatosiswithpolyangiitis #marketingauthorisation #microscopicpolyangiitis #Patients #TAVNEOS #treatmentoptions
https://www.europesays.com/europe/81529/

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

ST. GALLEN, Switzerland, June 26, 2026 /PRNewswire/ — Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL announced…
#Europe #EU #ChemoCentryx #EuropeanCommission #EuropeanMedicinesAgency #EuropeanUnion #FreseniusMedicalCare #granulomatosiswithpolyangiitis #marketingauthorisation #microscopicpolyangiitis #Patients #TAVNEOS #treatmentoptions
https://www.europesays.com/europe/80568/

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

ST. GALLEN, Switzerland, June 26, 2026 /PRNewswire/ — Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL announced…
#Europe #EU #ChemoCentryx #European #EuropeanCommission #EuropeanMedicinesAgency #EuropeanUnion #FreseniusMedicalCare #granulomatosiswithpolyangiitis #marketingauthorisation #microscopicpolyangiitis #Patients #TAVNEOS #treatmentoptions
https://www.europesays.com/europe/80232/

EMA validates Bayer’s asundexian application for ischaemic stroke

The European Medicines Agency (EMA) has validated Bayer’s marketing authorisation application for asundexian, an oral Factor XIa inhibitor,…
#Germany #DE #Europe #EU #Europa #Bayer #antiplatelettherapy #application #EuropeanMedicinesAgency #ischaemicstroke #marketingauthorisation #transientischaemicattack
https://www.europesays.com/germany/34461/

Press Release: Sanofi’s Rezurock approved in the EU to treat chronic graft-vs-host disease

Sanofi Winthrop Industrie Sanofi’s Rezurock approved in the EU to treat chronic graft-vs-host disease Paris, March 31, 20…
#France #FR #Europe #EU #Sanofi #chronicGVHD #clinicalstudies #EuropeanMedicinesAgency #graft-versus-hostdisease #marketingauthorisation #ROCKstar #SorbonneUniversity #stemcelltransplant #systemictherapy #TheEuropeanCommission #treatmentoptions
https://www.europesays.com/france/19451/

Norgine announces European Commission Marketing Authorisation for XOLREMDI® (mavorixafor), the first authorised treatment for patients with WHIM syndrome in the European Union

Approval follows a posi…
#Europe #EU #EuropeanCommission #(Mavorixafor) #CXCR4receptor #EuropeanMedicinesAgency #exceptionalcircumstances #hypogammaglobulinemia #marketingauthorisation #Norgine #Patients #pharmaceuticalcompany #primaryimmunodeficiency #WHIMsyndrome #whitebloodcells
https://www.europesays.com/europe/26264/

Sanofi’s Rezurock approved in the EU to treat chronic graft-vs-host disease

Sanofi Winthrop Industrie Sanofi’s Rezurock approved in the EU to treat chronic graft-vs-host disease Paris, March 31, 2026.…
#Europe #EU #chronicGVHD #clinicalstudies #EuropeanMedicinesAgency #EuropeanUnion #graft-versus-hostdisease #marketingauthorisation #ROCKstar #Sanofi #SorbonneUniversity #stemcelltransplant #systemictherapy #TheEuropeanCommission #treatmentoptions
https://www.europesays.com/europe/2080/

Commission bets on new incentives to improve access to medicines in the EU https://www.euractiv.com/section/health-consumers/news/commission-bets-on-new-incentives-to-improve-access-to-medicines-in-the-eu/?utm_source=dlvr.it&utm_medium=mastodon #incentives #marketingauthorisation #marketingprotection

Commission bets on new incentives to improve access to medicines in the EU https://www.euractiv.com/section/health-consumers/news/commission-bets-on-new-incentives-to-improve-access-to-medicines-in-the-eu/?utm_source=dlvr.it&utm_medium=mastodon #incentives #marketingauthorisation #marketingprotection

Commission bets on new incentives to improve access to medicines in the EU https://www.euractiv.com/section/health-consumers/news/commission-bets-on-new-incentives-to-improve-access-to-medicines-in-the-eu/?utm_source=dlvr.it&utm_medium=mastodon #incentives #marketingauthorisation #marketingprotection

Commission bets on new incentives to improve access to medicines in the EU https://www.euractiv.com/section/health-consumers/news/commission-bets-on-new-incentives-to-improve-access-to-medicines-in-the-eu/?utm_source=dlvr.it&utm_medium=mastodon #incentives #marketingauthorisation #marketingprotection

Commission bets on new incentives to improve access to medicines in the EU https://www.euractiv.com/section/health-consumers/news/commission-bets-on-new-incentives-to-improve-access-to-medicines-in-the-eu/?utm_source=dlvr.it&utm_medium=mastodon #incentives #marketingauthorisation #marketingprotection

Commission bets on new incentives to improve access to medicines in the EU https://www.euractiv.com/section/health-consumers/news/commission-bets-on-new-incentives-to-improve-access-to-medicines-in-the-eu/?utm_source=dlvr.it&utm_medium=mastodon #incentives #marketingauthorisation #marketingprotection

Commission bets on new incentives to improve access to medicines in the EU https://www.euractiv.com/section/health-consumers/news/commission-bets-on-new-incentives-to-improve-access-to-medicines-in-the-eu/?utm_source=dlvr.it&utm_medium=mastodon #incentives #marketingauthorisation #marketingprotection

Commission bets on new incentives to improve access to medicines in the EU https://www.euractiv.com/section/health-consumers/news/commission-bets-on-new-incentives-to-improve-access-to-medicines-in-the-eu/?utm_source=dlvr.it&utm_medium=mastodon #incentives #marketingauthorisation #marketingprotection