Regulators say the company’s AFX endovascular graft system with Strata material — used for abdominal aortic aneurysm repair — is at greater risk for type III endoleaks compared with other devices for the same indication. News Alerts
Scott Gottlieb’s work to speed approval of generics and his calls for drug price transparency were cited in his selection to Modern Healthcare’s annual ranking. The number of women on the list doubled this year. Medscape Medical News
Generic buprenorphine and naloxone sublingual film may increase access to treatment for opioid dependence, the agency said. FDA Approvals
The FDA has cleared an auricular neurostimulation device to help reduce symptoms of opioid withdrawal, including cravings, agitation, anxiety, and depression. FDA Approvals
MindMotion GO is a computer-based mobile neurorehabilitation system for patients with light- and medium-severity neurological impairments. FDA Approvals
The US suicide rate in adults continues to rise dramatically, says a new CDC report, with nearly 45,000 deaths attributed to suicide in 2016 alone. Medscape Medical News
The US suicide rate in adults continues to rise dramatically, says a new CDC report, with nearly 45,000 deaths attributed to suicide in 2016 alone. Medscape Medical News
Inotersen has won recommendation of the EMA’s Committee for Medicinal Products for Human Use for treatment of hereditary transthyretin amyloidosis. International Approvals
Fluids spilled on the consoles might seep inside and corrode circuit boards or otherwise cause the intra-aortic balloon pump systems to malfunction, regulators say. News Alerts
The Omnipod DASH uses a Bluetooth-enabled touch-screen controller and smartphone apps for viewing data. FDA Approvals
The possible presence of embedded or loose particulate matter on the syringe plunger has triggered a voluntary recall of two lots of naloxone hydrochloride injection. News Alerts
The FDA wants to make the review and approval of biosimilars a priority and is touting the latest approval as proof of this process. FDA Approvals
The FDA alerts providers that the 2-year death toll involving the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System is up to 12 worldwide. News Alerts
Although largely preventable, surgical fires continue to happen, prompting the FDA to issue a safety communication on contributing factors and ways to reduce the risk. News Alerts
The FDA has approved baricitinib 2-mg tablets for the treatment of moderately to severely active rheumatoid arthritis in adults, but declined to approve the 4-mg tablets. FDA Approvals
The recall, affecting more than 200,000 devices, is due to the possibility of interruption in the electrical connection between the system’s power source and the HVAD controller. News Alerts
The EMA’s Committee for Medicinal Products for Human Use recommends against approval of eteplirsen for Duchenne muscular dystrophy but extends approval of ataluren to younger patients with the disease. International Approvals
A European Medicines Agency (EMA) panel has recommended granting marketing authorization for the atypical antipsychotic brexipiprazole for the treatment of schizophrenia. International Approvals
An expert panel of the European Medicines Agency has recommended granting marketing authorization for erenumab, the first human monoclonal antibody for migraine prevention. International Approvals
The FDA has approved a combination of amlodipine besylate and celecoxib (Consensi, Kitov Pharma) for individuals with osteoarthritis pain and hypertension. FDA Approvals
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