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ACHEMA MIDDLE EAST 2026
5th LNP Formulation & Process Development Summit

Tag: FDA

FDA Approval of Gonorrhea Medications Broadens Oral Options

FDA Approvals
The U.S. Food and Drug Administration has approved two new oral medicines for the treatment of uncomplicated urogenital gonorrhea, marking an important regulatory step...

FDA Takes Steps to Decrease Animal Testing of New Medicines

Clinical Trials
The FDA has gone on to publish new guidance, which is aimed at reducing or stopping toxicity studies of monoclonal antibody-based drugs in non-human primates -...

AI-Assisted Fetal Screening Sets New Standard at Mount Sinai

Americas
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

Americas
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

Americas
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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