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Results For "biologic"

971 News Found

Merck announces FDA acceptance of biologics license application for Clesrovimab
Drug Approval | December 17, 2024

Merck announces FDA acceptance of biologics license application for Clesrovimab

An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season


CuraTeQ Biologics receives positive opinion for biosimilar Zefylti
Drug Approval | December 14, 2024

CuraTeQ Biologics receives positive opinion for biosimilar Zefylti

Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells


Biocon Biologics recognized as Asia IP Elite for 2024 by IAM
News | December 12, 2024

Biocon Biologics recognized as Asia IP Elite for 2024 by IAM

Biocon Biologics is among the two pharmaceutical companies from India in the 93 companies featuring on the Asia IP Elite 2024 list


FDA accepts supplemental Biologics License Application for Roche’s Columvi combination
Drug Approval | December 06, 2024

FDA accepts supplemental Biologics License Application for Roche’s Columvi combination

For people with relapsed or refractory diffuse large B-cell lymphoma


USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI
News | November 11, 2024

USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI

The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants


Briefs: Sun Pharmaceutical Industries and Biocon Biologics
News | November 04, 2024

Briefs: Sun Pharmaceutical Industries and Biocon Biologics

The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI


AGC Biologics begins operations at new manufacturing building in Copenhagen
News | October 14, 2024

AGC Biologics begins operations at new manufacturing building in Copenhagen

The new facility uses the latest mammalian systems and single-use technology, including a production line with eight 2,000 L bioreactors


Biocon Biologics’ sponsored report suggests ways to increase adoption of Biosimilars in poor countries
Policy | October 09, 2024

Biocon Biologics’ sponsored report suggests ways to increase adoption of Biosimilars in poor countries

Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines


Biocon Biologics refinances US$ 1.1 billion debt through USD bonds, new syndicated facility
News | October 04, 2024

Biocon Biologics refinances US$ 1.1 billion debt through USD bonds, new syndicated facility

US$ 800 million senior secured notes, the largest high yield debut USD bond issuance from India in the last 10 years


USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
Drug Approval | September 30, 2024

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations