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Posted today in New Drug Applications

ZS Pharma Announces FDA Acceptance of ZS-9 New Drug Application

ZS Pharma, Inc. (Nasdaq:ZSPH), today announced that its New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalemia, has been accepted for filing by the United States Food and Drug Administration (FDA). We have been informed that the Prescription Drug User Fee Act (PDUFA) goal date for a decision by the...

Posted today in Medical

Health Tip: After You Finish a Marathon

-- You've just finished a grueling 26-mile race and your body aches all over. What should you do? The American Council on Exercise offers this advice: Take five-to-10 minutes to cool down. Change clothes right away, so you stay dry and warm. Perform gentle stretches. Ice sore muscles and joints. Treat yourself to a gentle massage. Rest and let...

Posted today in Medical

Health Tip: Teach Kids to Protect Themselves

-- Every child will face danger in his or her life, and it's up to parents to equip children with the tools needed to minimize the chances of harm. The National Crime Prevention Council offers this advice: Make sure your child always knows how to contact you. Set a rule that your child must ask permission before going anywhere without you. Talk...

Posted 3 days ago in FDA Alerts

Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use

ISSUE: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration....

Posted today in Medical

Health Highlights: July 29, 2015

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Larger U.S. Health Care Spending Increases Expected in Coming Years The recent slowdown in U.S. health care spending increases is coming to an end, according to projections released Tuesday by federal government actuaries. Health spending will grow...

Posted today in Medical

Taking St. John's Wort for Depression Carries Risks: Study

St. John's wort is a popular herbal therapy for depression, but a new Australian study highlights the fact that "natural" does not always equal "safe." Using reports filed with Australia's drug safety agency, the researchers found that adverse reactions to St. John's wort were similar to those reported for the antidepressant fluoxetine -- better known...

Posted today in Clinical Trials

Ignyta Announces FDA Clearance of IND for RXDX-107

(BUSINESS WIRE)-- Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for Ignyta's new chemical entity RXDX-107, a next-generation alkyl ester of bendamustine encapsulated in human serum albumin (HSA) to form...

Posted today in Medical

U.S. Medical Groups Join to Fight Prescription Painkiller Abuse

Led by the American Medical Association, a group of 27 major U.S. medical organizations are banding together to tackle the continuing epidemic of narcotic painkiller abuse. "We have joined together as part of this special Task Force because we collectively believe that it is our responsibility to work together to provide a clear road map that will...

Posted today in Clinical Trials

Sanofi Announces That First LixiLan Phase III Study Met Primary Endpoint

Sanofi announced today that the LixiLan-O Phase III clinical trial met its primary objective in patients with type 2 diabetes treated with metformin. The fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide, a GLP-1 RA, demonstrated statistically superior reduction in HbA1c (average blood glucose over the previous three months)...

Posted today in Medical

Certain Antibiotics Linked to Hearing Loss, Mouse Study Finds

A certain class of antibiotics used to treat deadly bacterial infections puts patients at high risk for hearing loss, research in mice suggests. Newborns with life-threatening infections are often given these antibiotics, the researchers said. Investigators focused on aminoglycoside antibiotics, which doctors rely on to treat meningitis, bacteremia,...

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Recently added consumer and prescribing information: Daklinza, Praluent, Odomzo, Technivie, Rexulti, Entresto, Orkambi, Viberzi, Stiolto Respimat, Kybella

Posted in Blog

Drug Shortages: Has the FDA Response Made an Impact?

Rationing of much needed medications for patients is a scary thought for me as a healthcare professional. I can understand when an orphan drug may go in short supply for a rare disease, but when commonly used medications like antibiotics and intravenous fluids become scarce, I wonder what the forces are that cause this to […]

Posted in Blog

Harnessing the Power of the Poliovirus as a Cancer Cure

Polio, a highly infectious and crippling disease, was certainly one of the most feared viruses in the 20th century. Each year, thousands of children were left paralyzed. Polio has been successfully eliminated in the U.S. for decades due to a widespread vaccine program. So why would a group of researchers be interested in injecting the […]

Posted in Blog

Biosimilars in 2015: What Can We Expect?

On Friday, March 6th, 2015 the FDA approved Sandoz’s Zarxio, the first official biosimilar that will be made available in the U.S. Zarxio, a recombinant granulocyte colony-stimulating factor used to boost white blood cells after cancer treatments, is the long-awaited biosimilar for filgrastim (Amgen’s Neupogen). The FDA noted in their briefs that Zarxio was “highly […]

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