Regulatory
Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, announced that it has acquired marketing approval for Revcovi 2.4 mg for intramuscular injection [Elapegademase] from the Ministry of Health, Labor and Welfare .
Today, Celgene submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its ozanimod for adults with relapsing forms of multiple sclerosis (RMS).
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.
BioArctic AB comments on the decision by Nasdaq Stockholm to halt trading in BioArctic due to large movements in the share price.
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.
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.
labfolder is the first company amongst electronic laboratory notebook (ELN) and laboratory information management (LIMS) software vendors to announce its highly-ranked Net Promoter Score® (NPS®).
In a Phase III trial, a higher proportion of deaths was observed in the venetoclax arm compared to the control arm of the trial.
PRESS RELEASES