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Results For "BLA"

301 News Found

Lecanemab granted Fast Track designation by the U.S. FDA
Biotech | December 24, 2021

Lecanemab granted Fast Track designation by the U.S. FDA

Alzheimer's disease is a serious, progressive and devastating disease with few treatment options


U.S. FDA grants De Novo Clearance for Philips IVC filter removal laser sheath
Medical Device | December 23, 2021

U.S. FDA grants De Novo Clearance for Philips IVC filter removal laser sheath

Philips’s CavaClear is intended to safely ablate tissue to remove embedded IVC filters


Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


U.S. FDA approves first and only injectable option for HIV prevention
Drug Approval | December 21, 2021

U.S. FDA approves first and only injectable option for HIV prevention

Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition


CellCarta acquires Biogazelle to strengthen its genomic capabilities
Medical Device | December 15, 2021

CellCarta acquires Biogazelle to strengthen its genomic capabilities

While continuing to offer its current breadth of genomic services, Biogazelle will become CellCarta's Center of Excellence for the development of complex genomic biomarker assays


Landbell and GreenForest solutions announce JV to reduce plastic waste
Sustainability | December 13, 2021

Landbell and GreenForest solutions announce JV to reduce plastic waste

The company will provide recyclability services to brands with a final goal to help them move to fully recyclable packaging


Lilly's bamlanivimab with etesevimab authorized for emergency use in Covid-19 patients under 12
Drug Approval | December 06, 2021

Lilly's bamlanivimab with etesevimab authorized for emergency use in Covid-19 patients under 12

Expanded EUA includes both treatment of patients with Covid-19 and post-exposure prophylaxis (PEP) in high-risk pediatric and infant patients


Lupin and Biomm  tie-up for pegfilgrastim in Brazil
News | December 05, 2021

Lupin and Biomm tie-up for pegfilgrastim in Brazil

Lupin had earlier received the U.S. FDA acceptance of the Biologics License Application (BLA) for Its proposed biosimilar


Eris signs JV with MJ Biopharm to supply insulin in India
News | December 05, 2021

Eris signs JV with MJ Biopharm to supply insulin in India

MJ will be paid a one-time lumpsum licence fee of Rs 15 crore


Merck showcases potential for several cancers, MS and lupus
News | November 22, 2021

Merck showcases potential for several cancers, MS and lupus

Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline