#Novartis #FDAApproval #HealthcareInnovation

FDA Grants Traditional Approval to First Complement Inhibitor for Primary IgA Nephropathy

Author(s): MedEdge MEA

Novartis has received traditional approval from the US Food and Drug Administration (FDA) for Fabhalta® (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

Fabhalta is the first and only complement inhibitor approved for this indication and follows its accelerated approval in 2024 for reducing proteinuria in patients with primary IgAN. The approval was granted under the FDA’s priority review pathway - Read More.

Related Articles

View All
BD Completes Acquisition of Critical Care from Edwards Lifesciences MedEdge MEA

BD announced it has completed the acquisition of Edwards Lifesciences’ Critical Care product group, which will be renamed as BD Advanced Patient Monitoring. BD Advance...

Read More
Women in Finland to benefit from early detection of osteoporosis Infomedix International

Public mammography screening provider in Finland mobilizes against osteoporosis The Finnish mammography provider Suomen Radiologikeskus Oy has signed an agreement with...

Read More
What’s new in Apple’s health features for billions? MedEdge MEA

Apple unveiled breakthrough sleep and hearing health features coming to the Apple Watch and AirPods Pro 2 that further deliver on Apple’s commitment to health with experi...

Read More
New diagnostic technique improves breast cancer screening Infomedix International

Flexible coils for magnetic resonance imaging are being designed to search for breast cancer faster and with less disadvantages. In a project funded by the Austrian Scien...

Read More
Pfizer Launches Digital Hub for Simplified Healthcare Access MedEdge MEA

Pfizer introduced PfizerForAll, a user-friendly digital platform designed to make access to healthcare and managing health and wellness more seamless for people across th...

Read More
Artificial Intelligence: A Tool At The Service Of Big Data Infomedix International

From the high tech to the medical sector, AI is showing all its resources, opening the doors to many global innovations. In a rapidly changing world, modern society is...

Read More
LIFEPAK 35: What do you know about this new Device? MedEdge MEA

Stryker announced the launch of LIFEPAK 35 monitor/defibrillator, the latest product in the monitor/defibrillator space, offering advanced technology and built on an intu...

Read More
Henry Schein UK announces expanded and updated CRITERION brand Infomedix International

Henry Schein UK announced today the expansion of the company’s CRITERION® brand, which includes gloves as well as soon a head-to-toe line of personal protective equipment...

Read More
FDA approves Alecensa as first adjuvant treatment for people... MedEdge MEA

Basel- April 2024- Roche announced that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment following tumour resection f...

Read More
Menu
Categories
How does it work