August 6, 2021
The US Food and Drug Administration (FDA) has approved a new enzyme replacement therapy, avalglucosidase alfa (Nexviazyme, Genzyme), for patients aged 1 year and older with […]
August 4, 2021
The US Food and Drug Administration has cleared the FreeStyle Libre 2 iOS application for use with compatible iPhones. The new app works with the FreeStyle […]
August 2, 2021
Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus […]
July 22, 2021
The US Food and Drug Administration (FDA) has fully approved the combination of the immunotherapy pembrolizumab (Keytruda) plus the multiple receptor tyrosine kinase inhibitor lenvatinib (Lenvima) for […]
July 21, 2021
The Food and Drug Administration has approved the first high-frequency spinal cord stimulation (SCS) therapy for treating painful diabetic neuropathy (PDN). The approval is specific for […]
July 19, 2021
The US Food and Drug Administration (FDA) has approved the use of the transplant drug tacrolimus (Prograf) for the prevention of organ rejection in adult and […]
July 19, 2021
The US Food and Drug Administration (FDA) has granted a full approval for belumosudil (Rezurock) for the treatment of adult and pediatric patients 12 years and […]
July 16, 2021
The US Food and Drug Administration (FDA) has issued a notice about potential mechanical failures and biocompatibility concerns with MAGEC system devices from NuVasive. MAGEC is […]
July 2, 2021
Medtronic Vascular has issued a recall for certain models of its Angiographic Guidewire Component, used during angiography and interventional procedures, because the devices weren’t sterilized before […]