The approval by the DCGI comes following recommendations by the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation(CDSCO)
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
WHO’s post EUA inspection found deficiencies in Good Manufacturing Practice at the facility
It is the fourth vaccine to get the nod for 12 years and older after Biological E’s Corbevax, Bharat Biotech’s Covaxin and Zydus Lifesciences Zy-CoV-D
First of three Amneal biosimilars expected for U.S. approval and launch in 2022
Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy
It would be the first protein-based alternative available in Israel
Novavax' vaccine has received authorizations of the vaccine in over 170 countries
SAGE recommends additional third dose of the vaccine administered to immunocompromised persons
Lupin had earlier received the U.S. FDA acceptance of the Biologics License Application (BLA) for Its proposed biosimilar
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