FDA OKs Combo Therapy for Aggressive Thyroid Cancer

FDA OKs Combo Therapy for Aggressive Thyroid Cancer


The U.S. Food and Drug Administration on Friday approved Novartis AG’s combination therapy to treat an aggressive type of thyroid cancer.

The therapy, which uses Novartis’ Tafinlar and Mekinist, was approved to treat anaplastic thyroid cancer that cannot be removed surgically or has spread to other parts of the body, and has a type of abnormal gene known as BRAF V600E.

This is the first FDA-approved treatment for patients with this form of thyroid cancer and the third type of cancer with this specific gene mutation, the FDA said > >> read more ...

FDA OKs Emergency Radiation Treatment for Nuclear Event

FDA OKs Emergency Radiation Treatment for Nuclear Event


Pluristem Therapeutics Inc, a developer of placenta-based stem cell products, said the U.S. Food and Drug Administration has cleared the emergency use of its therapy to treat acute radiation exposure in a nuclear event.
Pluristem said it will start preparations to keep an emergency stock of PLX-R18 on hand for use in such events.

Full approval of the drug will depend on the results of a Phase III clinical trial. Pluristem said on Monday it is in discussions with the FDA and several U.S. agencies to clear the path for such a large final-stage study. > >> read more ...

FDA Approves First Drug for Inherited Kidney Disease

FDA Approves First Drug for Inherited Kidney Disease


The U.S. Food and Drug Administration has approved the first drug to slow kidney decline in patients with the most common inherited kidney disease.

Jynarque (jihn-AR’-kew), from Japan’s Otsuka Pharmaceutical, was approved Tuesday for autosomal dominant polycystic kidney disease.

The progressive genetic disorder is the fourth-leading cause of kidney failure. It causes fluid-filled cysts to develop in and damage kidneys.

The FDA rejected it in 2013 but approved it after the drugmaker did an additional study. That one-year study, involving 1,370 patients with advanced disease, found the drug on average slowed kidney function decline about 35 percent more than dummy pills. > >> read more ...

Cannabis-Based Epilepsy Drug Gets Positive Review: FDA

Cannabis-Based Epilepsy Drug Gets Positive Review: FDA


GW Pharmaceuticals’ cannabis-derived medicine for severe childhood epilepsy won a favorable review from U.S. Food and Drug Administration (FDA) staff on Tuesday, boosting hopes for its approval in the world’s biggest drugs market.

Shares in the company, which has operations in Britain and the United States, were 11 percent higher in early Nasdaq trade on the news.

GW’s medicine Epidiolex, which is given as a syrup, is a purified form of cannabidiol, one of the active ingredients found in marijuana. It contains less than 0.1 percent of tetrahydrocannabinol, the substance that makes people high. > >> read more ...

206 Million Eggs Recalled Over Salmonella Fears: FDA

206 Million Eggs Recalled Over Salmonella Fears: FDA


Rose Acre Farms in Seymour, Indiana, has voluntarily recalled 206,749,248 eggs due to fears they may have been contaminated with salmonella.

Thus far, 22 illnesses have been reported.

Salmonella can cause fever, diarrhea, nausea, and vomiting in healthy people, but can cause serious infections and even deaths in the elderly and in those with compromised immune systems.

The eggs were distributed in the following states: Colorado, Florida, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia to both retail stores and restaurants. > >> read more ...

FDA Approves AI Device to Detect Diabetic Eye Disease

FDA Approves AI Device to Detect Diabetic Eye Disease


U.S. health regulators said on Wednesday it will allow sale of the first medical device that uses artificial intelligence (AI) software to detect greater than a mild level of the most common cause of vision loss among more than 30 million Americans living with diabetes.

The device, called IDx-DR and produced by Iowa-based IDx LLC, is the first to receive Food and Drug Administration authorization that provides a screening decision without need for a clinician to also interpret the image or results. That makes it usable by health care providers not normally involved in eye care, such as primary care physicians who interact far more frequently with patients with diabetes. > >> read more ...

FDA Puts Restrictions on Birth Control Implant

FDA Puts Restrictions on Birth Control Implant


The U.S. Food and Drug Administration (FDA) on Monday slapped restrictions on the sale of Bayer AG’s implanted birth control device Essure, two years after the agency put a severe warning label on the product.
The FDA said https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604098.htm some women were not being properly informed of the risks associated with Essure before getting implanted.

The FDA’s restrictions will limit the sale of Essure only to healthcare facilities that provide full information about the device’s risks and benefits, the agency added. > >> read more ...

FDA Orders Recall of Salmonella-Tainted Herbal Supplement

FDA Orders Recall of Salmonella-Tainted Herbal Supplement


The FDA ordered Triangle Pharmanaturals to pull its herbal supplements off the market because some of its products tested positive for salmonella, part of a nationwide outbreak linked to the ingredient kratom.

The Food and Drug Administration said Tuesday that it took the rare step of ordering the recall because Triangle Pharmanaturals of Las Vegas refused to cooperate with U.S. regulators. Companies typically comply with government requests and voluntarily recall tainted products. > >> read more ...

FDA Approves Diabetes Glucose-Monitoring System

FDA Approves Diabetes Glucose-Monitoring System


The U.S. Food and Drug Administration on Tuesday approved DexCom Inc.’s monitoring system to check blood sugar levels in children and adults suffering from diabetes, which can be used along with devices such as insulin pumps.

The company’s shares rose as much as 3.7 percent to $72.75 in regular trading on Tuesday and closed at $69.99.

This is the first glucose monitoring system permitted by the agency that can be used with other compatible medical devices, the FDA said. > >> read more ...

FDA Sued Over Delay in E-Cigarette Review

FDA Sued Over Delay in E-Cigarette Review


Several anti-smoking groups are suing the Food and Drug Administration over a decision by Trump administration officials to delay the review of e-cigarettes.

The lawsuit filed Tuesday in federal court argues that the FDA didn’t follow proper requirements last year when it decided to push back the deadline for makers of e-cigarettes to submit their products for review. The groups say the delay poses a threat to children’s health.

“The FDA offered no meaningful justification for ripping a hole in the statutory framework,” according to the lawsuit filed by the American Heart Association, the American Academy of Pediatrics, the Campaign for Tobacco-Free Kids and others. > >> read more ...