Tag: FDA
FDA to radiologists: stop using any Multidata Systems devices
At least two devices distributed in U.S. without FDA approval. There have been at least two Multidata medical devices that the company manufactured and distributed in the United States for which FDA never received nor reviewed... read more
FDA Approves Zinplava to Reduce Recurrence of Clostridium difficile Infection in Adult Patients
FDA Approves Merck's ZINPLAVA (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection (CDI) in Adult Patients Receiving Antibacterial Drug Treatment for CDI Who Are at High Risk of CDI Recurrence.... read more
Cefiderocol, A Novel Investigational Siderophore Cephalosporin, Demonstrated Potent Activity Against Multi-Drug Resistant Gram-Negative Pathogens
Cefiderocol showed potent activity against Gram-negative pathogens, including carbapenem-resistant strains of Pseudomonas aeruginosa and Acinetobacter baumannii as well as carbapenem-resistant Enterobacteriaceae. The results... read more
FDA Approves sNDA for Label Changes to ADASUVE
The FDA has approved the supplemental New Drug Application for label changes to ADASUVE (loxapine) inhalation powder. ADASUVE is the first orally inhaled medication for the acute treatment of agitation associated with bipolar... read more
FDA Warns About Hepatitis B Reactivation from Hepatitis C Antivirals
The FDA issued a warning yesterday about the risk of hepatitis B virus becoming active again in patients with current or previous infection who received treatment with hepatitis C virus treatments.... read more
FDA approves automated insulin delivery device for type 1 diabetes
The Food and Drug Administration (FDA) has approved a device that automatically monitors blood glucose levels and delivers insulin when appropriate, for people aged 14 years and older who have type 1 diabetes.... read more
Shortages Of Essential Emergency Care Drugs Increase, Study Finds
The problems persist even after Congress in 2012 gave the FDA enhanced powers to respond when drug levels are low. At some hospitals, posters on the wall in the emergency department list the drugs that are in short supply... read more
