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Results For "Europe"

997 News Found

Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy
News | June 06, 2025

Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy

Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with Spinal Muscular Atrophy (SMA)


Shilpa Medicare partners with Orion for Recombinant Human Albumin for European market
Supply Chain | May 24, 2025

Shilpa Medicare partners with Orion for Recombinant Human Albumin for European market

Orion will be the exclusive partner for the distribution, marketing, and sales of Shilpa's Recombinant Human Albumin in Europe


Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site
Drug Approval | May 06, 2025

Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site

he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice


Biocon Biologics receives positive CHMP opinions for biosimilar Denosumab in Europe
Drug Approval | April 28, 2025

Biocon Biologics receives positive CHMP opinions for biosimilar Denosumab in Europe

The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited


European Commission approves Merck’s Capvaxive for prevention of invasive pneumococcal disease
Drug Approval | March 27, 2025

European Commission approves Merck’s Capvaxive for prevention of invasive pneumococcal disease

EC decision marks the fourth approval for CAPVAXIVE for pneumococcal vaccination in adults


European Commission approves Biocon Biologics' Ustekinumab Biosimilar
News | February 21, 2025

European Commission approves Biocon Biologics' Ustekinumab Biosimilar

YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease


Merck’s Welireg receives European approval for two indications
News | February 19, 2025

Merck’s Welireg receives European approval for two indications

WELIREG is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union


European Commission expands Jemperli plus chemotherapy approval for endometrial cancer
Drug Approval | January 21, 2025

European Commission expands Jemperli plus chemotherapy approval for endometrial cancer

Jemperli plus chemotherapy is the only immuno-oncology-based treatment to show statistically significant and clinically meaningful OS benefit in the overall population


ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe
News | January 10, 2025

ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe

According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually


European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors
Drug Approval | November 21, 2024

European Commission approves Pfizer’s HYMPAVZI for treatment of severe Hemophilia A or B without inhibitors

HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors