Drug Approval | December 08, 2023
Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions
Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions
The drug will be marketed by Sun Pharma under the brand name RYTSTAT
Impressive safety and efficacy for solid cancer patients followed by global clinical study plan
Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint
This first joint plan on One Health aims to create a framework to integrate systems and capacity so that we can collectively better prevent, predict, detect, and respond to health threats
First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations
Doubling of median overall survival seen in QuANTUM-First results presented at EHA Presidential Symposium
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