Food and Drug Administration (FDA)
NEWS
It is the first BeiGene-discovered drug to be approved.
The U.S. Food and Drug Administration approved Shionogi’s Fetroja as a treatment for adult patients with complicated urinary tract infections caused by a number of Gram-negative microorganisms.
Management sciences researchers will help agency understand, improve pharmaceutical quality management
The advisory committee voted 14 to 2 that the benefits of the drug did not outweigh the risks to support approval. The FDA is not obligated to follow the recommendation, but typically do.
The letter outlines multiple failures, including failure to have adequate written procedures for the receipt, identification and handling of raw materials and failure to adequately clean equipment and utensils.
In its announcement, Solid Biosciences said a patient in its second cohort who was dosed in October experienced a serious adverse event that was deemed related to the drug.
In Phase 2b development for the treatment of life-threatening fungal infections
Bridge Therapeutics Inc. announced that it has received feedback from the Food and Drug Administration from a Pre-Investigational New Drug meeting for the development of BT-219, a therapy to treat Opioid Dependence.
The division previously had three clinical divisions and one nonclinical division. Under the restructuring, it will six divisions, three for oncology.
JOBS
IN THE PRESS