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Results For "marketing-authorization"

160 News Found

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


Pfizer and OPKO update on the Biologics License Application for Somatrogon
Biotech | January 22, 2022

Pfizer and OPKO update on the Biologics License Application for Somatrogon

Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward


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


Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021
News | January 12, 2022

Veristat supported marketing applications for 12 % of all FDA Novel Drug Approvals in 2021

This surpasses the number of approvals supported in 2020


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


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