FDA Gives Breakthrough Device Designation for Puzzle Medical Devices Inc.’s Transcatheter Heart Pump
The U.S. Food and Drug Administration (FDA) has granted Puzzle Medical Devices Inc. a Breakthrough Device Designation for its minimally invasive transcatheter heart pump. The revolutionary device is meant for patients with minimal trauma for blood components to...
J&J Submits Single Dose COVID-19 Vaccine to FDA
Janssen Biotech, a Johnson & Johnson company, submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its single dose COVID-19 vaccine. The submission is based on topline safety and efficacy data from the Phase...
Moderna’s COVID-19 Vaccine Approved by Singapore
Singapore has become the first Asian country that has approved the Moderna COVID-19 vaccine as it begins its efforts in implementing its immunization program. The first shipment of Moderna’s vaccine is expected sometime around March. Currently, 175,000 of Singapore’s...
FDA Places Interim Process to Communicate Issues Found During Record Reviews
The U.S. Food and Drug Administration (FDA) has outlined an interim process for drug developers to relay any problems identified during record reviews instead of, or in advance of, preapproval inspections. Their responses will be taken into consideration before action...
Sputnik V Vaccine Efficacy Validated by Peer Review
Despite facing much public scrutiny for rushing the Sputnik V vaccine, the efficacy of Russia’s vaccine has been validated in a peer-reviewed study that was published in The Lancet. The Lancet published an interim analysis of Phase III data that Sputnik V has...
FDA Grants Approval for ADMA BioCenters Plasma Collection Facility
ADMA Biologics announced today (2/1) that the U.S. Food and Drug Administration (FDA) has granted approval for the ADMA BioCenters Plasma Collection Facility in Knoxville, Tennessee. Adam Grossman, President and Chief Executive Officer of ADMA, stated, “The approval...