Tag: FDA
Physicians at RSNA make case for contrast enhanced ultrasound
The procedure, which was OK'd by the FDA this year for liver screening, but is currently not approved in the U.S. for cardiac disease shows particular value in imaging children who may otherwise have to undergo a CT... read more
Value of Expedited Drug Approvals for Cancer Care
This study examines potential benefits of cancer drugs approved by the FDA on the basis of surrogate endpoints.... read more
How to prevent spread of the skin infection impetigo
Impetigo is a contagious skin infection that's preventable and can be treated with antibiotics, the U.S. Food and Drug Administration says. Impetigo can strike anytime but is more common during warm weather months. More... read more
FDA Approves Defibrillator That Automatically Adjusts Pacing
The FDA has cleared the Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device (Medtronic) for patients with heart failure.... read more
Hepatitis B Drug Combination Approved
Tenofovir-alafenamide combination approved by the FDA for chronic hepatitis B infection.... read more
New discovery paves way for pancreatic cancer treatment
Patients suffering from pancreatic cancer may soon face better treatment options due to the latest discovery by Dr. Reginald Hill, who's research focuses on drugs that are already approved by the FDA.... read more
FDA Approves Carnexiv Injection for Seizures
The FDA has approved Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations for adults with certain seizure types.... read more
FDA approves new device for prevention of recurrent strokes in certain patients
FDA approved the Amplatzer PFO Occluder device which reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent... read more
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
