President Trump on Monday called for more clear disclosure of medical expenses. Democratic presidential contenders may also delve into healthcare costs during debates later this week. News Alerts
Botox is the first neurotoxin to be approved in the US to treat upper limb spasticity for pediatric patients aged 2 years and older. FDA Approvals
Bremelanotide becomes the second FDA-approved drug for hypoactive sexual desire disorder in premenopausal women. It is self-injected at least 45 minutes before sexual activity. FDA Approvals
The new approval is for patients with germline BRCA-mutated, HER2 negative locally advanced or metastatic breast cancer. International Approvals
The FDA has approved tezacaftor/ivacaftor tablets for use in children as young as 6 years with cystic fibrosis with certain genetic mutations in the CFTR gene. FDA Approvals
The FDA has approved tezacaftor/ivacaftor tablets for use in children as young as 6 years with cystic fibrosis with certain genetic mutations in the CFTR gene. FDA Approvals
Sterility concerns prompt RXQ Compounding to recall all unexpired sterile products, including injectable bevacizumab, epinephrine, ketamine, fentanyl, and midazolam, among others. News Alerts
The manufacturer has received multiple complaints about the balloon catheters bursting below the rated burst pressure, which could cause serious injury or death. News Alerts
Liraglutide is the first noninsulin agent approved to treat pediatric type 2 diabetes in nearly 20 years; approval comes at a time when doctors are increasingly concerned about type 2 diabetes in kids. FDA Approvals
Handling errors with leuprolide acetate depot formulations have reportedly led to problems such as leakages from the syringe or failure to deliver implants from the applicator, the EMA says. News Alerts
The FDA warns about the potential risk for serious or life-threatening infections with the use of investigational fecal microbiota for transplant. News Alerts
The new recall of six lots brings the total to 41 lots of bulk losartan potassium sold to Golden State Medical Supply of California. News Alerts
The FDA has now approved first-line use in head and neck cancer on the basis of clinical trial results that were recently described as ‘practice changing.’ FDA Approvals
The FDA has granted accelerated approval to polatuzumab for previously treated diffuse large B-cell lymphoma. FDA Approvals
The IB-Stim uses a small electrical nerve stimulator to help reduce functional abdominal pain in patients aged 11 to 18 years with IBS. FDA Approvals
The ReStore system is designed like a garment that connects to waist pack and cables that help lift the patient’s affected leg in synchronized timing with their natural walking pattern.
Eversense, Senseonics’ long-term implantable continuous glucose monitor, can now be used "nonadjunctively" so that patients don’t need to do fingersticks for insulin dosing decisions. FDA Approvals
In addition to mepolizumab subcutaneous injection given by a health provider, the drug will also be available as an autoinjector and prefilled safety syringe for at-home use. FDA Approvals
The agency acted to limit the future use of the devices in routine clinical care of intermittent claudication but left open their use in critical limb ischemia. News Alerts
The CGRP antagonist was first approved by the FDA last year for the prevention of migraine in adults. FDA Approvals
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