FDA Approvals

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...

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 to Move Towards Single Clinical Study for Approvals

FDA Approvals

The U.S. Food and Drug Administration - U.S. FDA is on the verge of introducing a significant policy transition that may as well streamline the...

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...

Bayer Secures EU Approval for Lynkuet Menopause Treatment

Drug Development

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...

Subscribe Our Newsletter

White Papers

Whitepapers

FDA Approvals

About us

Resources

Advertise

Subscribe