News about "European Medicines Agency "

TolerogenixX Secures EU Orphan Drug Designation for MIC-Lx in Living-Donor Kidney Transplantation

European Commission grants orphan status to Tolerogenix’s personalized cell therapy following EMA recommendation, strengthening its regulatory pathway alongside recent PRIME designation.

European Medicines Agency | 14/07/2026 | By News Bureau

Orchid Pharma Partners with Pharmasyntez to Commercialise Exblifep in Russia

Orchid Pharma has signed an exclusive licensing and supply agreement with Pharmasyntez JSC for Exblifep in Russia. The partnership is expected to strengthen access to advanced antimicrobial therapies while addressing the growing challenge of antibiotic resistance.

European Medicines Agency | 09/07/2026 | By News Bureau

Vertex to Acquire Crinetics Pharmaceuticals for USD 10 Billion

Under the terms of the agreement, Vertex will acquire all outstanding shares of Crinetics for USD 85 per share in cash, representing a net transaction value of approximately USD 8.8 billion after accounting for estimated cash acquired.

European Medicines Agency | 08/07/2026 | By Abha

EMA Panel Recommends Revoking EU Authorisation for Tavneos Over Data Integrity Concerns

CHMP concludes pivotal clinical trial data cannot reliably demonstrate the drug’s efficacy, advises discontinuation for new patients and enhances liver monitoring for existing users.<br />

European Medicines Agency | 29/06/2026 | By News Bureau

EMA Recommends Approval of Datroway for First-Line Treatment of Triple-Negative Breast Cancer

AstraZeneca and Daiichi Sankyo have received a positive recommendation from the European Medicines Agency's CHMP for Datroway as a first-line treatment for unresectable or metastatic triple-negative breast cancer in patients who are not eligible for immunotherapy, supported by Phase 3 trial results demonstrating improved survival and disease control.

European Medicines Agency | 29/06/2026 | By News Bureau

IntraBio Submits EMA Variation Application for AQNEURSA in Ataxia-Telangiectasia

IntraBio has submitted a variation application to the European Medicines Agency (EMA) for AQNEURSA as a treatment for Ataxia-Telangiectasia. If approved, it would become the first authorised therapy for this disorder in the European Economic Area.

European Medicines Agency | 06/06/2026 | By News Bureau

EMA Recommends XFG-Targeted COVID-19 Vaccines for 2026-2027 Immunisation Campaign

The European Medicines Agency’s Emergency Task Force has recommended updating COVID-19 vaccines to target the XFG variant for the 2026–2027 vaccination season, aiming to enhance protection against circulating SARS-CoV-2 strains.

European Medicines Agency | 01/06/2026 | By News Bureau |  163

European Medicines Agency Launches Advisory Group to Tackle Vaccine Hesitancy

‘European Medicines’ Advisory Group aims to rebuild public trust, strengthen vaccine communication and counter misinformation across Europe.

European Medicines Agency | 02/05/2026 | By News Bureau

AbbVie Submits FDA Application for SKYRIZI Subcutaneous Induction in Crohn's Disease

AbbVie Inc. submits an application to the US Food and Drug Administration (FDA) for SKYRIZI (risankizumab-rzaa) subcutaneous induction in Crohn’s disease, supported by Phase 3 AFFIRM data, offering a potential new treatment option.

European Medicines Agency | 29/04/2026 | By News Bureau |  138

Soligenix Reports Phase 3 FLASH2 Interim Results for HyBryte in Cutaneous T-Cell Lymphoma

Soligenix reports Phase 3 FLASH2 interim results for HyBryte in Cutaneous T-Cell Lymphoma, with the study recommended for early termination due to futility.

European Medicines Agency | 29/04/2026 | By News Bureau |  101