Tag: U.S. Food and Drug Administration

World's Most Expensive Gene Therapy Zolgensma Treats Rare Genetic Disease In Infants

The Food and Drug Administration has approved the use of Zolgensma in treating a rare genetic disease in infants. At a one-time treatment, Zolgensma costs at least $2.1 million.

Medicine May 25, 2019

Sunscreen Chemicals Absorbed By Skin Can Enter Human Bloodstream

Certain sunscreen chemicals absorbed by the skin can enter the bloodstream. The Food and Drug Administration urges sunscreen manufacturers to conduct more research on their ingredients to see if there are health risks.

Healthy Living/Wellness May 8, 2019

Unsafe Levels Of Arsenic Found In Some Bottled Water Brands

Market watchdog Consumer Reports has named six popular bottled water brands that have arsenic levels that are at or above the 3 ppb federal limit. Long-term exposure to such levels could lead to serious health effects.

Public Health April 23, 2019

FDA Bans Sale Of Pelvic Mesh Product Amid Reports Of Injuries In Women

The FDA said pelvic mesh makers failed to provide a reasonable assurance that their products are safe and effective to use. This led to the agency banning the sale and distribution of all such products in the market.

Public Health April 17, 2019

FDA Updates Fluoride Level Standard For Bottled Water

FDA proposed to update the allowable levels of fluoride in bottled water. The action was made to ensure that the public gets the benefits of fluoride, without experiencing its adverse effects.

Public Health April 4, 2019

National Cancer Institute Director Ned Sharpless To Be Acting FDA Commissioner

Physician-scientist Norman ‘Ned’ Sharpless will take over FDA leadership from outgoing Commissioner Scott Gottlieb starting April. Sharpless is expected to continue the agency’s critical public health mission.

Public Health March 14, 2019

FDA Cautions Against ‘Vaginal Rejuvenation’ Treatments, Says They Might Cause Serious Side Effects

The FDA says vaginal rejuvenation devices have not gone through the correct approval process required to show they’re effective or let alone safe to use. These alternative treatments have increased in popularity thanks to the media.

Public Health July 31, 2018

FDA Continues To Stop Companies From Selling Kratom Supplements That Could Be Linked To Salmonella

The Food and Drug Administration cracked down again on companies that continue to sell the kratom supplement. The unknown product is linked to a recent outbreak of salmonella, which has so far affected 130 people in the United States.

Public Health May 22, 2018

FDA Warns Of EpiPen Shortage: How To Be Prepared When You Need An Emergency Allergy Shot

EpiPens and generic versions are facing a shortage in the United States, says the FDA. Here's how to deal with this issue and survive the shortage.

Public Health May 10, 2018

Caffeine Crackdown: FDA Takes Step To Block Consumer Sales Of Pure Caffeine In Bulk

Since 2015, the FDA has been cracking down on the sales of pure caffeine. A new guidance will make selling pure caffeine in bulk unlawful.

Public Health April 14, 2018

New FDA Guidelines Eases Approval For Neurology Drugs Including Treatment for Alzheimer's

The Food and Drug Administration recognized the urgent need for new medical treatments for many neurological disorders. The agency proposed to ease the guidelines for the approval of new drugs for Alzheimer's, epilepsy, migraine, and ALS.

Medicine February 19, 2018

FDA To Crack Down On Dangerous Homeopathic Drugs: Here's Why You Should Avoid The Alternative Remedies

The United States Food and Drug Administration will take a closer look at the homeopathic drugs in the market from now on. Homeopathic medicines are based on an 18th century idea that has since been invalidated by numerous modern studies.

Public Health December 20, 2017

Dog Bone Treats Unsafe: Here Are Other Foods You Shouldn't Feed Your Canine Friend

Processed bone treats could be deadly to your dogs, according to the FDA. At that, here are more unsafe food for dogs you shouldn't give to your pets.

Public Health November 29, 2017

Hepatitis B And Hepatitis C: Improved Efforts Can Wipe Out The Diseases By 2030 In US

A research committee has laid out a plan to successfully eradicate hepatitis B and C from the United States by 2030. The plan suggests that the federal government acquire license rights for expensive drugs used to treat these diseases.

Public Health March 29, 2017

FDA Warns Against Hacking Medical Devices Like Artificial Pacemakers: New Cybersecurity Guidelines Set

The threat of hacking comes with the many technological advancements of late, and medical devices are not an exception. The FDA now issues stricter guidelines when it comes to the privacy of medical facilities and medical device users.

Biotech December 31, 2016

Blue Bell Wants To Return To Normalcy After Listeria Outbreak

Blue Bell wants the precautions, placed on the company by federal regulators, to be removed. The company proposes that a testing approach should replace it, which would require it to destroy products only if listeria contamination is confirmed.

Public Health December 31, 2016

Not-So-Wholesome Products From Whole Foods? FDA Slams Whole Foods For 'Serious Violations'

The FDA has warned Whole Foods regarding several instances of food safety violations that inspectors found in the company's Massachusetts facility. Violations include failing to sanitize food preparation surfaces and placing food near dirty dishes.

Public Health June 16, 2016

FDA Unveils New Food Label To Help Consumers Make Healthy Choices

The FDA has released a new food label to help people make better health choices. The new Nutrition Facts includes revamps on vitamin and information on 'added sugars.'

Public Health May 22, 2016

First Drug To Treat Psychosis Linked To Parkinson's Gets FDA Approval

FDA approves the first Parkinson’s-related psychosis drug. Nuplazid (pimavanserin) tablets are designed to treat psychosis-related delusions and hallucinations among some patients with Parkinson’s disease.

Medicine April 30, 2016

CVS Recalls Herbal Tea Due To Possible Salmonella Contamination

CVS pharmacy announced that it has recalled an herbal tea product due to possible salmonella contamination risk. No reports of illnesses have been reported and the store has already removed all the recalled items from its shelves.

Public Health April 26, 2016

FDA Moves To Revoke Approval Of Pig Drug Over Cancer Risks To Consumers

The FDA on April 8 moved to rescind the approval of the pig drug carbadox over concerns that it could leave cancerous residue in pork. The drug manufacturer, however, insists that carbadox is safe.

Life April 10, 2016

FDA Issues New Rules For Transporting Food Safely

The U.S. Food and Drug Administration (FDA) issued a new rule on food transportation. This will cover shippers, carriers and receivers to prevent food safety problems that might pose a threat to consumer health.

Life April 7, 2016

FDA Issues Draft Guidance For Development Of Generic Anti-Abuse Opioids

The FDA has released a draft guidance on creating generic versions of anti-abuse opioid drugs. This move is part of the agency's overall strategy to stop abuse and misuse of the substance by boosting abuse-deterrent opioid technologies.

Life March 25, 2016

FDA Wants To Ban Use Of Powdered Medical Gloves

FDA wants to ban the use of powdered medical gloves in the U.S. The agency said powdered gloves may pose health hazards such as respiratory allergies and inflammation to medical staff, patients and exposed individuals.

Life March 21, 2016

Salmonella Outbreak That Sickened 11 Prompts Recall Of Pistachios

Salmonella outbreak has sickened 11 people and hospitalized two in California. Authorities said the most probable sources of the infection are the pistachio products of Wonderful Pistachios, Trader Joe's and Paramount Farms, which all have announced voluntary food recalls.

Life March 10, 2016

US Senate Confirms Robert Califf To Run FDA

The FDA has a new commissioner amid the pressure the agency faces. With only one year left of the Obama administration, Dr. Robert Califf has a lot of tasks to finish.

Life February 24, 2016

FDA Issues Blood Donation Guidelines Amid Zika Virus Outbreak

FDA issues blood donation guidelines in the midst of the Zika virus infection outbreak. Even if the U.S. blood supply remains unaffected, the agency wants to carry out safety measures early on.

Life February 16, 2016

FDA Strengthens Rules For Using Mesh Implants In Pelvic Surgeries

The FDA said pelvic mesh implants used for pelvic organ prolapse surgeries in women will now be classified as class III or high-risk devices. It also started to require a pre-market approval application from manufacturers showing the products' safety and effectiveness.

Life January 6, 2016

FDA Approval Of First-Of-A-Kind Drugs Highest In 19 Years

The FDA approved 45 drugs with never-before-sold ingredients in the U.S. last year, surpassing 2014’s total of 41 approved drugs. Rising prescription drug prices, R&D challenges, and the development of new cancer treatments are some crucial industry issues in 2016.

Life January 5, 2016

FDA Gives Approval To Bridion, A Surgery Drug That Reverses The Effects Of Muscle Relaxants

The FDA has approved the surgery drug Bridion (sugammadex) for reversing the effects of muscle relaxants. Bridion can speed up recovery from medications such as vecuronium bromide and rocuronium bromide.

Life December 16, 2015

Sweet Leaf Tea Recalls 1.5 Million Bottles Of Tea Over Glass Fragments

Sweet Leaf Tea recalled 1.5 million glass bottles of tea due to possible presence of glass fragments. The company has already received four complaints but no injuries have been reported so far.

Life December 11, 2015

FDA Gives Approval To Blood Cancer Drug Empliciti

The FDA has granted approval to the use of the drug Empliciti in combination with two other drugs for treating patients with multiple myeloma. The drug Empliciti is the second FDA-approved monoclonal antibody used for multiple myeloma treatments.

Life December 1, 2015

Costco Says It Will Not Sell Genetically-Modified Salmon

Costco joins the list of stores that will not sell genetically-modified salmon recently approved by the U.S. Food and Drug Administration. The wholesale firm is said to continue its development monitoring.

Life November 27, 2015

FDA May Change Food Labels To Cut Added Sugar Intake

The U.S. FDA recently proposed a plan that will change nutrition labels and include the amount of added sugar that products contain. The agency recommends Americans to cut down added sugar intake to 10 percent of daily calories.

Life November 12, 2015

FDA Approves Sale of New Snus Smokeless Tobacco Products

Snus, or tobacco powder, has been a popular non-smoking tobacco product in Sweden. The FDA cleared distribution of the product to the U.S. market.

Society November 11, 2015

FDA Sends Warning To Three Companies Over Direct-To-Consumer Gene Tests

FDA warning letters were sent to diagnostic companies DNA4Life, DNA-CardioCheck, Inc. and Interleukin Genetics, Inc. The notifications had to do with direct-to-consumer genetic tests believed to be marketed to the public without FDA clearance.

Life November 11, 2015

FDA Panel Recommends Approval Of Merck Drug Sugammadex To Reverse Effect Of Muscle Relaxant

After several years and rejections, Merck & Co's drug sugammadex gets another chance to win FDA approval when an independent panel voted for the administration to do so this month. If it does come to pass, sugammadex will be the first drug of its kind in the U.S. to address neuromuscular block problems during surgery.

Life November 9, 2015

Gilead Four-In-One HIV Drug Wins FDA Approval

Genvoya is approved for previously untreated HIV patients weighing at least 77 pounds, and adults whose HIV-1 infection is suppressed at present because of antiretroviral therapy. It is an HIV four-in-one drug following Gilead Sciences' earlier version called Stribild.

Life November 6, 2015

FDA Approves Nucala As Treatment For Severe Asthma

The U.S. Food and Drug Administration approved GlaxoSmithKline's first anti-asthma drug that inhibits interleukin-5. Nucala has shown significant reduction in asthma attacks among patients in their clinical trial.

Life November 5, 2015

Hormel Foods Recalls Skippy Peanut Butter Over Metal Shavings Scare

About 153 cases of Skippy peanut butter after its makers suspected that certain jars contained small metal shavings. This is the second incident of food contamination this month.

Life October 31, 2015

Merck's Star Drug Keytruda Improves Overall Survival Of Lung Cancer Patients

Merck's Keytruda showed promise in its latest trial in prolonging survival rates among patients with advanced lung cancer. The FDA approved the drug earlier this month but wanted more detailed data on its effect on survival rates among patients who did not respond to other treatment options.

Life October 28, 2015

FDA Approves Merrimack's Pancreatic Cancer Drug Onivyde But Treatment Comes With Boxed Warning

The FDA approved the distribution of new pancreatic cancer drug Onivyde. However, because of its several consideraby fatal side effects, boxed warnings are to be included to guide clinicians in prescribing the drug.

Life October 23, 2015

AbbVie Hepatitis Drugs Viekira Pak, Technivie Could Cause Serious Liver Damage: FDA

AbbVie manufactured drugs Viekira Pak and Technivie could cause liver damage, according to the FDA. Patients taking the drugs are urged to talk to their doctors should they experience signs and symptoms of liver impairments.

Life October 23, 2015

Medline Industries Recalls Mislabeled Acetaminophen: Affected Products Could Lead To Liver Failure

The recall covers lot number 45810 of Medline's 500mg uncoated, compressed Acetaminophen tablets, with item number OTC20101 on their bottles and an expiration date of May 2018. The affected lot was distributed across the United States from June 12 to Sept. 18, 2015.

Life October 19, 2015

GoGo Squeez Applesauce Recalled Due To Mold Threat

Because of a recent production issue leading to mold contamination, a popular children’s snack maker recalled “a small number of pouches" of its applesauce product. Affected are applesauce packs with a “Best Before Date” of June 30, 2016 to July 26, 2016.

Life October 17, 2015

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