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Results For "marketing-authorization"

155 News Found

Jardiance is first and only treatment approved in Europe for chronic heart failure
Drug Approval | March 07, 2022

Jardiance is first and only treatment approved in Europe for chronic heart failure

The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe


VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod
Biotech | February 27, 2022

VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod

If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.


Canada approves plant-based Covid-19 vaccine
News | February 25, 2022

Canada approves plant-based Covid-19 vaccine

Medicago and GSK collaborated on Covifenz, an adjuvanted plant-based vaccine


Novavax ships first consignment of Covid-19 vaccine to European countries
News | February 24, 2022

Novavax ships first consignment of Covid-19 vaccine to European countries

The first wave of shipments includes several countries, such as Germany, France and Austria


Prestige BioPharma’s facility receives EU-GMP certification
Biotech | February 22, 2022

Prestige BioPharma’s facility receives EU-GMP certification

The facility will manufacture its Herceptin biosimilar, Tuznue


Glenmark launches nasal spray to treat Covid-19
News | February 09, 2022

Glenmark launches nasal spray to treat Covid-19

Glenmark received manufacturing and marketing approval from DCGI for Nitric Oxide Nasal Spray (NONS) as part of accelerated approval process


Lupin signs distribution agreement with Medis for Orphan Drug NaMuscla@
News | February 09, 2022

Lupin signs distribution agreement with Medis for Orphan Drug NaMuscla@

NDM disorders are a group of rare, inherited neuromuscular disorders which is characterized by the inability to relax muscles following voluntary contraction


Biogen and Xbrane announce commercialization and license agreement for biosimilar to treat rheumatoid arthritis
Biotech | February 08, 2022

Biogen and Xbrane announce commercialization and license agreement for biosimilar to treat rheumatoid arthritis

Under the terms of the agreement, Biogen will make an upfront payment of US $ 8 million to Xbrane


Israel signs deal to purchase Novavax’ Covid-19 vaccine
Biotech | January 29, 2022

Israel signs deal to purchase Novavax’ Covid-19 vaccine

It would be the first protein-based alternative available in Israel