News about "European Medicines Agency (EMA"

AbbVie Seeks EMA Approval for Subcutaneous SKYRIZI in Crohn's Disease

AbbVie submits an European Medicines Agency (EMA) application for subcutaneous SKYRIZI induction in adults with moderately to severely active Crohn’s Disease (CD), supported by phase 3 AFFIRM data.

European Medicines Agency (EMA) | 27/08/2026 | By News Bureau

Fresenius Wins US FDA and EMA Review Acceptance for Vedolizumab Biosimilar

Fresenius has secured US Food and Drug Administration (FDA) and European Medicines Agency (EMA) review acceptance for its vedolizumab biosimilar, targeting Ulcerative Colitis (UC) and Crohn's Disease (CD) in adults.

European Medicines Agency (EMA) | 03/08/2026 | By News Bureau |  513

EU Approves Datroway for First-Line Metastatic TNBC

The European Union (EU) has approved AstraZeneca and Daiichi Sankyo's Datroway for first-line metastatic Triple Negative Breast Cancer (TNBC), backed by positive phase 3 survival and PFS results.

European Medicines Agency (EMA) | 01/08/2026 | By News Bureau |  115

EU Approves Pfizer-BioNTech XFG-Adapted COVID-19 Vaccine

The European Commission (EC) has approved Pfizer-BioNTech's XFG-adapted COVID-19 vaccine, with more than 5 billion vaccine doses distributed worldwide.

European Medicines Agency (EMA) | 30/07/2026 | By News Bureau

CHMP Recommends AstraZeneca's Trixeo for EU Approval in Asthma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended EU approval of AstraZeneca's Trixeo for asthma maintenance, backed by positive phase 3 KALOS and LOGOS trial results.

European Medicines Agency (EMA) | 25/07/2026 | By News Bureau |  139

CHMP Recommends EU Approval of Roche's Susvimo

The Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of Roche's Susvimo, the first continuous delivery treatment offering an alternative to regular eye injections for wet Age-related Macular Degeneration (AMD).

European Medicines Agency (EMA) | 25/07/2026 | By News Bureau

EMA Accepts Bexsero Label Update for Meningitis B Booster

The European Medicines Agency (EMA) has accepted a label update for Bexsero that could enable a single booster dose to protect individuals aged 10 years and older previously vaccinated against Meningitis B.

European Medicines Agency (EMA) | 21/07/2026 | By News Bureau |  104

Formycon and OneSource Partner to Manufacture Biosimilars

Formycon and OneSource Specialty Pharma have partnered to manufacture biosimilars, with OneSource providing integrated Drug Substance (DS) and Drug Product (DP) manufacturing from its Bengaluru biologics facility.

European Medicines Agency (EMA) | 15/07/2026 | By News Bureau |  112

EMA Fast-Tracks Review of New Metastatic Pancreatic Cancer Drug

The European Medicines Agency (EMA) has initiated a phased review of a new medicine for metastatic pancreatic cancer, accelerating its assessment to address a significant unmet medical need.

European Medicines Agency (EMA) | 09/07/2026 | By News Bureau

Lupin Secures EMA Approval for Expanded NaMuscla Pediatric Use

Lupin has received EMA approval to expand the pediatric indication of NaMuscla, including two new capsule strengths of 62 mg and 83 mg.

European Medicines Agency (EMA) | 03/07/2026 | By News Bureau |  341