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Results For "biologics"

463 News Found

Biocon Biologics recognized as an Asia IP Elite for 2023
News | December 17, 2023

Biocon Biologics recognized as an Asia IP Elite for 2023

Biocon Biologics is one among the three pharmaceutical companies from India to be featured on this year's list


Syngene concludes acquisition of biologics manufacturing facility from Stelis Biopharma
News | December 03, 2023

Syngene concludes acquisition of biologics manufacturing facility from Stelis Biopharma

The acquisition will add 20,000 litres of installed biologics drug substance manufacturing capacity for Syngene


Biocon Biologics completes Integration of Viatris' Biosimilar business
News | December 01, 2023

Biocon Biologics completes Integration of Viatris' Biosimilar business

The full transition of Viatris' biosimilars operations to Biocon Biologics in Europe represents another significant milestone


Biocon Biologics receives MHRA, UK Approval for Biosimilar Aflibercept ‘Yesafili’
News | November 14, 2023

Biocon Biologics receives MHRA, UK Approval for Biosimilar Aflibercept ‘Yesafili’

Yesafili, received marketing authorization approval from the European Commission for the European Union


Biocon Biologics announces divestment of two non-core branded formulations
News | November 09, 2023

Biocon Biologics announces divestment of two non-core branded formulations

Total transaction value of the divestment is Rs. 3,660 million


USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
Drug Approval | October 26, 2023

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer


Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations
Drug Approval | October 14, 2023

Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations

The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally


Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart
Drug Approval | October 09, 2023

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart

The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022


Biocon Biologics receives European Commission approval for biosimilar of Aflibercept ‘Yesafili’
Drug Approval | September 21, 2023

Biocon Biologics receives European Commission approval for biosimilar of Aflibercept ‘Yesafili’

The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway