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FDA Approves Two New Indications for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, Dec. 20, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO® (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have...
Source: Johnson and Johnson - December 21, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenita...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Godly gift for arthritis pain
Big Pharma is at it again… Creating and selling a drug that causes thousands of heart attacks and strokes each year. In 2015, the FDA asked drug makers to strengthen their warning labels. Since then, most have listed their dangerous side effects on the bottle. But one manufacturer thought they didn’t have to warn people about their dangerous drug. They marketed their product as a “unique” breakthrough. They even published studies promising it was “safe for long-term use.” 1 The drug is a 7-year-old arthritis drug called Actemra. It’s made by the Swiss pharmaceutical company Roche. ...
Source: Al Sears, MD Natural Remedies - October 5, 2017 Category: Complementary Medicine Authors: Al Sears Tags: Anti-Aging Source Type: news

Diagnostic reference levels and median doses for common clinical indications of CT: findings from an international registry
ConclusionsDRLs for CTDIvol and DLP for EUCLID clinical indications from diverse organizations were established and can contribute to dose optimization. These values were usually significantly higher in the US than in Europe.Key Points•Registry data were used to create benchmarks for 10 common indications for CT identified by the European Society of Radiology.•Observed US radiation doses were higher than European for 9 of 10 indications (except chronic sinusitis).•The presented diagnostic reference levels and median doses highlight potentially unnecessary variation in radiation dose.
Source: European Radiology - October 13, 2021 Category: Radiology Source Type: research

PathMaker Neurosystems Launches European Clinical Trial
PathMaker Neurosystems, a clinical stage company in the bioelectronic medicine space, is seeking to change the treatment paradigm of patients suffering from spasticity secondary to stroke with the MyoRegulator device. The company, which has a presence in both Boston and Paris, has initiated the first patient in its European clinical trial for the MyoRegulator. In addition, MyoRegulator is in clinical trials in the U.S. “We expect to have our first regulatory clearance in less than two years,” Dr. Nader Yaghoubi, president and CEO of PathMaker Neurosystems, told MD+DI. “...
Source: MDDI - September 6, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news