Tag: FDA
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...
Bayer Secures EU Approval for Lynkuet Menopause Treatment
Bayer has secured regulatory clearance in both the United States and the European Union for Lynkuet, a non-hormonal therapy for vasomotor symptoms (VMS), marking...
FDA Unveils Plausible Mechanism Pathway for Custom Therapies
The US Food and Drug Administration (FDA) has unveiled a new regulatory framework designed to accelerate the approval of personalised therapies by easing traditional...
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