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
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
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
These building blocks are essential to modern therapeutics, including fast-growing GLP-1 treatments for weight loss and diabetes
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
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