A spokesperson from the U.S. Food and Drug Administration (FDA) reported that the FDA has no intentions of resuming onsite GMP foreign inspections for non-“mission critical” operations during the COVID-19 pandemic. Further, the agency intends on continuing...
In their updated safety communication, the US FDA (Food and Drug Administration) states that the safety and efficacy of robotically assisted surgical (RAS) devices is still to be determined in the prevention and treatment of breast cancer. While the use of RAS devices...
Marketed under the name, Comirnaty, The US FDA (Food and Drug Administration) granted the Pfizer-BioNTech COVID-19 vaccine full approval yesterday, the first COVID-19 vaccine to become fully licensed in the US. In the US, the vaccine is now approved for people aged 16...
The US FDA (Food and Drug Administration) has approved Abbott’s Amplatzer Amulet left atrial appendage occlude for the treatment of nonvalvular atrial fibrillation in people with a higher risk of stroke and systemic embolism. Abbott’s Amulet is characterized by...
The US FDA (Food and Drug Administration) has lifted their clinical hold on Rocket Pharmaceuticals for their experimental gene therapy program for the treatment of Danon disease. Following the decision, Rocket announced it will resume patient enrollment later this...
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