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133 News Found

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis
Drug Approval | September 19, 2024

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Roche’s PiaSky approved in the EU for treatment of people with PNH
Drug Approval | September 03, 2024

Roche’s PiaSky approved in the EU for treatment of people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH
News | August 27, 2024

Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


Fasenra approved in China for the treatment of severe eosinophilic asthma
Drug Approval | August 25, 2024

Fasenra approved in China for the treatment of severe eosinophilic asthma

Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control


Farxiga approved in the US for the treatment of paediatric type-2 diabetes
Drug Approval | June 14, 2024

Farxiga approved in the US for the treatment of paediatric type-2 diabetes

Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date


GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
Drug Approval | April 17, 2024

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met


European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease
Drug Approval | March 13, 2024

European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease

PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally


Nucala approved in China for use in severe asthma with an eosinophilic phenotype
News | January 16, 2024

Nucala approved in China for use in severe asthma with an eosinophilic phenotype

Approval based on a separate phase III trial among Chinese patients reinforcing mepolizumab’s efficacy and safety data


Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24
Drug Approval | January 03, 2024

Alembic Pharmaceuticals received 8 USFDA approvals in Q3FY24

The company has received five final approvals


WHO issues warning on the surge of new age gateway devices among children
Healthcare | December 14, 2023

WHO issues warning on the surge of new age gateway devices among children

Mothers Against Vaping also highlights a recent study of young people at risk of experiencing significant respiratory symptoms after just 30 days of electronic cigarette and other new age gateway products use