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Results For "BLA"

267 News Found

Lupin launches Droxidopa capsules in the US
Drug Approval | September 29, 2021

Lupin launches Droxidopa capsules in the US

Droxidopa capsules, 100 mg, 200 mg, and 300 mg is a generic equivalent of Northera capsules, 100 mg, 200 mg, and 300 mg, of Lundbeck NA


Fortis Hospital conducts complex surgery to save a patient with recurrent heart failure
Hospitals | September 29, 2021

Fortis Hospital conducts complex surgery to save a patient with recurrent heart failure

A team of experts at Fortis Gurugram conducted 3-dimensional mapping with the help of the new system Carto version 7 to precisely map the source of the arrhythmia. It was detected that the arrhythmia was coming from the conduction system i.e. body’s natural wiring.


Eisai initiates rolling submission for Biological Licence Application of Lecanemab
Biotech | September 28, 2021

Eisai initiates rolling submission for Biological Licence Application of Lecanemab

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology


Fujifilm to verify effectiveness of AI technology in health screening services
Digitisation | September 27, 2021

Fujifilm to verify effectiveness of AI technology in health screening services

This project will be conducted at the “NURA,” a health screening centre that Fujifilm opened in India in February this year


Machine Learning to understand and prevent disease
Digitisation | September 17, 2021

Machine Learning to understand and prevent disease

Barbara Engelhardt moves her computational and statistics lab to Gladstone


Everest Medicines ties up with Providence Therapeutics to supply Covid-19 vaccines in Asia
Biotech | September 13, 2021

Everest Medicines ties up with Providence Therapeutics to supply Covid-19 vaccines in Asia

Everest gains access to a clinically validated mRNA platform and a potentially “best-in-class” mRNA COVID-19 vaccine with full technology transfer


US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184
Biotech | August 31, 2021

US FDA grants Lantern Pharma additional Orphan Drug tag for LP-184

The drug is also intended for the treatment of glioblastoma multiforme


European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo


Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection
Drug Approval | August 27, 2021

Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection

The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks