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Results For "Europe"

1035 News Found

Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart
Biotech | February 13, 2021

Biocon Biologics and Viatris receive European Commission approval for Kixelle, Biosimilar Insulin Aspart

The centralized marketing authorization granted by the EC is valid in all EU Member


Sandoz to acquire Just–Evotec Biologics facility for $300 million
News | August 03, 2025

Sandoz to acquire Just–Evotec Biologics facility for $300 million

The companies will now begin detailed contract negotiations and proceed with necessary consultations and approval processes


Fermenta receives CEP by EDQM for Vitadee 100 SD
Biotech | August 01, 2025

Fermenta receives CEP by EDQM for Vitadee 100 SD

Fermenta now becomes one of the only two companies globally to hold a CEP for this variant of Vitamin D3


Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine with near-zero GWP
Sustainability | July 31, 2025

Trixeo Aerosphere receives positive EU CHMP opinion as first inhaled medicine with near-zero GWP

Trixeo is the first pMDI medicine in AstraZeneca’s portfolio to use the near-zero GWP propellant


Roche updates on Elevidys gene therapy for Duchenne muscular dystrophy in EU
News | July 31, 2025

Roche updates on Elevidys gene therapy for Duchenne muscular dystrophy in EU

Elevidys is currently the only approved gene therapy that targets the root cause of Duchenne


Maziar Mike Doustdar appointed President and CEO of Novo Nordisk
People | July 31, 2025

Maziar Mike Doustdar appointed President and CEO of Novo Nordisk

Novo Nordisk will merge its Research & Early Development and Development functions into a single R&D unit


EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1
News | July 27, 2025

EMA’s CHMP recommends authorization of Moderna's Covid-19 vaccine Spikevax for SARS-CoV-2 Variant LP.8.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision


Indoco receives EU GMP certificate for its sterile manufacturing facility in Goa
News | July 26, 2025

Indoco receives EU GMP certificate for its sterile manufacturing facility in Goa

This GMP certification for our sterile drug product manufacturing facility, Goa Plant II is a testament to our relentless efforts to supply quality and affordable medicines across geographies


Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer
Drug Approval | July 21, 2025

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)


Concord Biotech announces successful completion EU GMP inspection at its API facility
News | July 18, 2025

Concord Biotech announces successful completion EU GMP inspection at its API facility

This achievement underscores our unwavering commitment to upholding the highest standards of quality, safety, and regulatory compliance