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First biosimilar erythropoiesis-stimulating agent backed by an FDA panel
Two-year study shows 2.8% improvement in disease-free survival versus placebo
Snail-paced regulators get up to Silicon Valley speed
Investigational compound previously received an orphan drug designation
Though hurdles remain, company plans to file a biologics license application soon
Treatment protects gut microbiome from antibiotic-mediated dysbiosis
First new treatment in more than 20 years
Agency cites lack of long-term endometrial safety data