Austrian company AOP Orphan Pharmaceuticals GmbH (AOP Health), a provider of integrated therapies for rare diseases and critical care, announced on Wednesday that the US Food and Drug Administration (FDA) has approved Rapiblyk (landiolol) for the treatment of supraventricular tachycardia, including atrial fibrillation and atrial flutter, in the critical care setting.
The approval was based on clinical trials demonstrating Rapiblyk's ability to rapidly reduce heart rate with minimal reduction of blood pressure.
This new treatment option will provide patients in the United States with a faster and more targeted approach to managing these conditions.
Orsini chosen as specialty pharmacy partner for ITVISMA (onasemnogene abeparvovec-brve)
Bonesupport shifts CERAMENT V review to FDA's De Novo pathway
Cosmo and Glenmark receive European marketing authorisation for Winlevi
Polarean expands XENOVIEW 3T Coil access with Philips compatibility
Ascletis selects ASC37 oral tablets as clinical development candidate
Medivir granted FDA orphan drug designation for MIV-711 in osteogenesis imperfecta
Novo Nordisk submits sNDA to FDA for for higher semaglutide injection dose
GE HealthCare receives FDA clearance for AI-powered Pristina Recon DL mammography system
Remington Medical's VascuChek 2.0 Cordless Bluetooth-Enabled Doppler Secures FDA Clearance