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Results For "European-Union"

203 News Found

European Commission approves Keytruda plus chemotherapy as neoadjuvant treatment for breast cancer
Drug Approval | May 25, 2022

European Commission approves Keytruda plus chemotherapy as neoadjuvant treatment for breast cancer

This Keytruda combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC


Pfizer offers patent-protected medicines on not-for-profit to 45 low income countries
News | May 25, 2022

Pfizer offers patent-protected medicines on not-for-profit to 45 low income countries

Pfizer calls upon global health leaders and organizations to join the Accord, bringing their expertise and resources to close the health equity gap


Vaxzevria approved in the EU as third dose booster against Covid-19
Drug Approval | May 23, 2022

Vaxzevria approved in the EU as third dose booster against Covid-19

Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine


Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe
News | May 21, 2022

Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe

The European Commission granted CMA in December 2021 for use of Nuvaxovid in individuals aged 18 and over, and Novavax filed for expanded CMA for use in adolescents aged 12 through 17 in March 2022


Sun Pharma to launch Brillo, a first-in-class oral lipid-lowering drug in India
Drug Approval | May 18, 2022

Sun Pharma to launch Brillo, a first-in-class oral lipid-lowering drug in India

Bempedoic Acid administered as a 180-mg dose, is approved by the USFDA and European Union for the treatment of hypercholesterolemia


Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years
Drug Approval | May 18, 2022

Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years

Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series


Myovant Sciences and Accord Healthcare partner to commercialise Orgovyx in Europe
Biotech | May 10, 2022

Myovant Sciences and Accord Healthcare partner to commercialise Orgovyx in Europe

Myovant to receive an upfront payment of US $50 million, is eligible to receive commercial launch, sales-based and other milestones totaling up to US $90.5 million


Pfizer to acquire Biohaven Pharmaceuticals for US $ 11.6 billion
Biotech | May 10, 2022

Pfizer to acquire Biohaven Pharmaceuticals for US $ 11.6 billion

Pfizer to commercialize NURTEC ODT (rimegepant), an innovative compound for the prevention and acute treatment of migraine, a condition with high unmet need


Ultomiris approved in the US for adults with generalised myasthenia gravis
Drug Approval | April 29, 2022

Ultomiris approved in the US for adults with generalised myasthenia gravis

Ultomiris showed early effect and lasting improvement in activities of daily living and has potential to reduce treatment burden with dosing every 8 weeks


Kapruvia approved by European Commission for hemodialysis patients
Drug Approval | April 28, 2022

Kapruvia approved by European Commission for hemodialysis patients

First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients