Turoctocog alfa pegol is an extended half-life factor VIII molecule for treatment and prophylaxis of bleeding episodes and perioperative management in adults and children with hemophilia A. FDA Approvals
The recall has been classified by the US Food and Drug Administration as class I, the most serious type. News Alerts
Fascioliasis (liver fluke infestation) is a waterborne and foodborne neglected tropical disease affecting an estimated 2.4 million people worldwide, with an additional 180 million at risk. FDA Approvals
After facing sharp criticism from readers, the American Academy of Neurology’s flagship journal has retracted an essay about a patient encounter that it acknowledged ‘contains racist characterizations.’ News Alerts
The potential risk of serious heart rhythm problems associated with fenspiride prompts the EMA’s safety committee to recommend suspending its use pending further review. Medscape Medical News
Mark Berman, MD, who was previously warned about marketing unapproved stem cell products, is now cited for marketing an unapproved device that claims to treat capsular contracture. News Alerts
Two FDA panels jointly recommended esketamine 28-mg single-use nasal spray for the patients with treatment-resistant depression. News Alerts
The FDA has sent warning letters to companies illegally marketing more than 58 products claiming to prevent, treat, or cure Alzheimer’s disease and other serious conditions. News Alerts
The extended indication for the device is based on results from the PREMIER trial. It is already approved for large or giant wide-necked intracranial aneurysms. FDA Approvals
Caplacizumab (Cablivi) injection is indicated in combination with plasma exchange and immunosuppressive therapy for adults with acquired thrombotic thrombocytopenic purpura (aTTP). FDA Approvals
Republicans and Democrats in Congress have already been targeting drug prices, but almost assuredly won’t approve an abortion ban. Medscape Medical News
The European CHMP has also started a review of bleeding risks with the new oral anticoagulant agents and is reexamining its previous recommendation against use of omega 3 fatty acids after MI. International Approvals
The European CHMP has also started a review of bleeding risks with the new oral anticoagulant agents and is reexamining its previous recommendation against use of omega 3 fatty acids after MI. International Approvals
The Committee for Medicinal Products for Human Use recommends new requirements for manufacturing to eliminate nitrosamine impurities, giving a ‘worst case’ estimate of the associated cancer risk. News Alerts
Interim data from a postapproval study suggest a higher risk for death than the risk seen in premarket studies and prompts a letter to providers from the FDA. News Alerts
FluMist for influenza returns as an option this year, although the American Academy of Pediatrics still prefers that kids get the shot. Homelessness is added as an indication for hepatitis A vaccination. Medscape Medical News
The introduction of abuse-deterrent OxyContin may be a factor in the sharp rise in hepatitis C infections in the United States because drug abusers switched to injectable heroin, research suggests. News Alerts
The company has received 58 complaints about the device locking up after a defibrillation shock is delivered, including six events in which the patient died after a delay in therapy. News Alerts
The company has received 58 complaints about the device locking up after a defibrillation shock is delivered, including six events in which the patient died after a delay in therapy. News Alerts
If approved, it would be the first oral add-on to insulin worldwide, but could only be used in patients in whom risk of diabetic ketoacidosis can be properly mitigated. International Approvals
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