Food and Drug Administration (FDA)
NEWS
A U.S. Food and Drug Administration (FDA) advisory panel voted 14 to 0 against recommending Neuronix’s NeuroAD system for the treatment of mild to moderate Alzheimer’s disease.
As America continues to grapple with the opioid crisis, nonprofit advocacy group Public Citizen is calling for the U.S. Food and Drug Administration to place a moratorium on the approval of any new opioid medications.
As Scott Gottlieb prepares to step down from his role as commissioner of the U.S. Food and Drug Administration, he sat down with Politico to talk about his two years at the helm of the regulatory agency and what regrets he may be leaving behind.
Shares of Jazz Pharmaceuticals are climbing in premarket trading following a late Wednesday announcement that the U.S. Food and Drug Administration granted approval for Sunosi, a treatment for people with narcolepsy.
Hitachi Chemical Diagnostics, Inc., a global leader in multiplex allergy in vitro diagnostics, announced today that it received 510 clearance from the U.S Food and Drug Administration for its new high capacity allergy testing instrument, OPTIGEN® AP 3600TM.
One year after spinning out from AstraZeneca’s MedImmune, Viela Bio is already anticipating filing a Biologics License Application with the U.S. Food and Drug Administration for its lead asset, inebilizumab.
The approval of Zulresso marks the first and only treatment for postpartum depression (PPD) approved by the U.S. Food and Drug Administration.
In a Phase III trial, a higher proportion of deaths was observed in the venetoclax arm compared to the control arm of the trial.
“With this drug, we are not only preventing that first heart attack, but potentially the second stroke and maybe that third fatal event,” stated Deepak Bhatt, the study’s lead investigator.
JOBS
IN THE PRESS