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Results For "European-Union"

191 News Found

VFMCRP receives EU approval for Tavneos for the treatment of ANCA-associated vasculitis
Drug Approval | January 20, 2022

VFMCRP receives EU approval for Tavneos for the treatment of ANCA-associated vasculitis

First launches expected in H1 2022


Novavax and Serum file EUA for Covovax in South Africa
Biotech | January 10, 2022

Novavax and Serum file EUA for Covovax in South Africa

Novavax' vaccine has received authorizations of the vaccine in over 170 countries


U.S. FDA approves Leo Pharma’s Adbry
Drug Approval | December 29, 2021

U.S. FDA approves Leo Pharma’s Adbry

Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022


Novartis collaborates with BeiGene to strengthen immunotherapy pipeline
Biotech | December 21, 2021

Novartis collaborates with BeiGene to strengthen immunotherapy pipeline

Innovative market development collaboration also signed, expanding the availability of select Novartis oncology products in regions across China currently not covered by Novartis


EMA approves Pfizer’s Covid-19 anti-viral candidate
News | December 17, 2021

EMA approves Pfizer’s Covid-19 anti-viral candidate

EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease


Algorithmic Biologics receives CE mark for Tapestry platform
Startup | December 10, 2021

Algorithmic Biologics receives CE mark for Tapestry platform

The platform’s technology works as a compression algorithm for molecular testing


European Commission approves Roche’s Gavreto
Drug Approval | November 22, 2021

European Commission approves Roche’s Gavreto

Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC


Moderna seeks approval from EMA for its Covid-19 vaccine for children between 6-11 years
News | November 10, 2021

Moderna seeks approval from EMA for its Covid-19 vaccine for children between 6-11 years

The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11


U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years
Drug Approval | October 22, 2021

U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years

Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option


Lincoln Pharma gets Australian TGA approval
News | October 08, 2021

Lincoln Pharma gets Australian TGA approval

The company plans to expand its portfolio in regulated markets aggressively