Tag:

Clinical Trial

FDA Approves First Non-Opioid Painkiller In 20+ Years: 'A Historic Milestone' FDA Approves First Non-Opioid Painkiller In 20+ Years: 'A Historic Milestone'
FDA Approves First Non-Opioid Painkiller In 20+ Years: 'A Historic Milestone' The Food and Drug Administration has approved a first-of-its-kind non-opioid pain medication, providing a new option for adults experiencing moderate to severe acute pain. Journavx received FDA approval, the agency announced on Thursday, Jan. 30. The drug developed by Boston-based Vertex Pharmaceuticals blocks sodium channels in the peripheral nervous system, preventing pain signals from reaching the brain. The approval marks the first new class of pain medicine in more than two decades and offers a potential non-addictive alternative to opioids. "Today's approval is a historic milestone f…
COVID-19: FDA Changes Course On Vaccine Authorization For Kids Under 5 COVID-19: FDA Changes Course On Vaccine Authorization For Kids Under 5
Covid-19: FDA Changes Course On Vaccine Authorization For Kids Under 5 Federal health officials delayed a planned public meeting to review Pfizer’s COVID-19 vaccine for children under five. Citing the need to see more data as part of its rolling application process, the Food and Drug Administration (FDA) announced on Friday, Feb. 11 that it would be delaying the planned meeting, raising questions about how soon children should get the COVID-19 shot. The FDA’s outside experts had been set to meet on Tuesday, Feb. 15 to discuss if children under the age of 5 could safely receive a low dose of the vaccine safely. Pfizer said on Friday that it will be waiting fo…