US revenue increased 43% to $12.9 billion, fueled by a 50% jump in volume, partially offset by a 7% decline in realized prices
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration
The company maintained a competitive ARPOB while steadily improving occupancy, driven by higher patient volumes and efficient capacity utilization
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
The facility is dedicated to breakthrough innovations in laboratory instruments that detect infectious diseases, cancer, and blood disorders
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