Tag: America
FDA Approves Inebilizumab-cdon for gMG Treatment in Adults
The U.S. Food and Drug Administration (FDA) has approved inebilizumab-cdon (Uplizna; Amgen) for the treatment of adults with generalized myasthenia gravis who are anti-acetylcholine...
US-UK Zero Tariff Deal Reshapes Pharmaceutical Trade Landscape
Key takeaways:
The UK secured exclusive zero percent tariff access for pharmaceuticals entering the US, removing a major source of trade uncertainty.
The revised...
AI-Assisted Fetal Screening Sets New Standard at Mount Sinai
Mount Sinai obstetricians have become the first in New York City to use FDA-cleared artificial intelligence technology designed to enhance prenatal ultrasound evaluations for...
FDA Clears Novartis Itvisma Gene Replacement Therapy for SMA
Novartis has secured US Food and Drug Administration (FDA) approval for Itvisma (onasemnogene abeparvovec-brve), a gene replacement therapy for spinal muscular atrophy (SMA).
The clearance...
FDA Clears Merck’s Keytruda with Padcev for Bladder Cancer
Key takeaways:
Merck’s FDA clearance introduces the first PD-1 inhibitor and ADC combination for cisplatin-ineligible MIBC patients, widening its position in the bladder cancer...
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