FDA Approves Abbott’s Amplatzer Amulet Fibrillation

FDA Approves Abbott’s Amplatzer Amulet Fibrillation

Aug 17, 2021 | News, Regulatory

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...
Rocket to Resume Clinical Trial following FDA Hold Lift

Rocket to Resume Clinical Trial following FDA Hold Lift

Aug 16, 2021 | News, Regulatory

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...
CytoDyn HIV Justification Report: Guidance From FDA

CytoDyn HIV Justification Report: Guidance From FDA

Aug 13, 2021 | News, Regulatory

The U.S FDA (Food and Drug Administration) has provided CytoDyn with guidance on its recent HIV BLA dose justification report, a crucial part of the company’s resubmission for its Biologics License Application (BLA) for HIV. CytoDyn is known for specializing in...