Sanofi secures two breakthrough nods in China for rare blood disorders
Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia
Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia
The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed
The inspection concluded with one minor observation in Form 483
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
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