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Tag: FDA

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

Migraine Prevention Drug Receives FDA Approval: Aimovig By Amgen Is The First Of Its Kind

Aimovig, designed for long-term migraine prevention, will now go on sale after receiving approval from the U.S. Food and Drug Administration. The drug is the first of its kind, and it could soon mean the end of chronic migraines.

Medicine May 18, 2018

FDA Approves Lucemyra, The First Non-Opioid Drug For Opioid Withdrawal Symptoms Up To 14 Days

The Food and Drug Administration approved of Lucemyra, a treatment for adults suffering from opioid withdrawal symptoms. It has been approved for patients to use up to 14 days.

Medicine May 16, 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

E-Cigarette Use In Classrooms Plummets, FDA Tries To Prevent Sales To Minors

After principals and teachers noticed an increase in the use of e-cigarettes in school, the FDA set out to encourage retailers to stop selling vapes to minors. Some companies have already begun to raise the purchasing age to 21.

Healthy Living/Wellness April 30, 2018

Marijuana-Based Drug For Seizures Gets Unanimous Recommendation From FDA Committee

An FDA advisory committee gave the go-ahead for Epidiolex, a marijuana-based drug that treats two rare and severe forms of epilepsy. The FDA is scheduled to vote this June.

Medicine April 20, 2018

A Seizure Drug Made From Marijuana Is This Close To Getting FDA Approval

GW Pharmaceuticals awaits FDA approval for Epidiolex, which contains an element derived from cannabis. It will treat children suffering from two rare forms of epilepsy by making their seizures less frequent.

Medicine April 18, 2018

FDA Issues First Ever Mandatory Recall For Contaminated Food: Kratom Products With Salmonella

The U.S. Food and Drug Administration issued a mandatory recall for all kratom products by Triangle Pharmanaturals. This is the first time that the FDA launched such an order, looking to stem the salmonella outbreaks related to the herbal supplement.

Public Health April 4, 2018

FDA Cracks Down On Salt Intake, Redefines What ‘Healthy’ Labels Mean

The FDA revised its nutrition plans, which follows through the efforts of the Obama administration. Among the targeted programs are reduced public sodium intake, better food labels, and full disclosure of product ingredients.

Public Health March 31, 2018

FDA Takes Action To Regulate Flavors In Cigarettes

The U.S. FDA announced it will regulate flavored tobacco products in an effort to reduce the number of young smokers. The agency is also looking to review policies on e-cigars and lowering nicotine content to a nonaddictive level.

Public Health March 20, 2018

FDA Plans To Lower Nicotine Content In Cigarettes To Non-Addictive Levels

In a historic move, the Food and Drug Authority announced its plan to reduce nicotine in cigarettes to non-addictive levels. This effort could lead to lower smoking rates and could address rising tobacco smoking-related deaths and diseases.

Public Health March 16, 2018

The FDA Is Taking Steps To Combat Opioid Addiction, Plans Expanded Access To Medication-Assisted Therapy

New Secretary of Health and Human Services Alex Azar has vowed to expand access to medication-assisted treatment for opioid addicts. He also announced that the FDA will issue two new guidances to combat America’s opioid crisis.

Medicine February 27, 2018

Antibiotic Clarithromycin Can Potentially Raise Risk Of Death In Patients With Heart Disease

FDA has released an alert cautioning against the prescription of clarithromycin to heart disease patients. The agency had advised health care providers to weigh the cons of the antibiotics because it can increase death risks in heart disease patients.

Public Health February 23, 2018

Drug For Treatment Of Peanut Allergy Nears Approval

After successful clinical trials, a new drug to treat peanut allergy is getting closer to approval. A large number of children suffering from peanut allergies can benefit from the drug.

Medicine February 21, 2018

Some People Are Using Diarrhea Meds To Get High, And The FDA Is Concerned

Individuals are abusing loperamide, an over-the-counter anti-diarrhea drug, by ingesting as much as 400 pills a day. Some patients say it can provide the same high feeling heroin and morphine can.

Public Health February 3, 2018

FDA Approves First Gene Therapy For Inherited Disease

Luxturna was recently approved for the treatment of a blindness-causing RPE65 gene mutation. With two injections in each eye, patients diagnosed with a hereditary retinal dystrophy would be able to experience improved vision.

Medicine December 20, 2017

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

FDA Gives Green Light To Monthly Injection For Opioid Addiction

The FDA gave its approval to a once-a-month injectable treatment for patients recovering from opioid addiction. What's the monthly cost of Suboxone and what are its side effects?

Medicine December 2, 2017

This Popular Vitamin To Make Hair Grow Faster Is Screwing Up Blood Tests

Biotin, a popular vitamin often used in supplements to increase hair growth, was found to be interfering with the results of blood tests. False results may lead to wrong health management or a misdiagnosis, and in one known case, death.

Medicine November 30, 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

Processed Bone Treats May Kill Your Dog, FDA Warns After 15 Dogs Die

The U.S. Food and Drug Administration warned that processed dog treats may be deadly to dogs. The FDA has received 68 reports of the product causing harm to a total of 90 dogs, with 15 of them being fatal cases.

Public Health November 29, 2017

Doctors Still Prescribe Codeine To Children After Tonsillectomy Despite FDA Black Box Warning

Despite a warning from the Food and Drug Administration about the safety risks of codeine, a new study found that 1 in 20 children was still getting the medication after undergoing tonsillectomy and adenoidectomy.

Medicine November 20, 2017

FDA Sets New Rules For Stem Cell Treatments

The FDA has set new rules to keep a check on regenerative medicine and stem cell therapy. The move will also crack down rogue clinics that provide questionable regenerative treatments.

Biotech November 18, 2017

World's First Digital Drug: FDA Approves Pill That Can Track If Patients Swallow It

The FDA recently approved Otsuka Pharmaceutical Co Ltd's Abilify MyCite. The drug is the world's first digital pill that can check if patients are taking their medication or not.

Medicine November 14, 2017

Curing Blindness Through Gene Therapy Might Soon Be Allowed By The FDA

Patients whose blindness is a result of an RPE65 gene might soon consider Luxturna, a form of gene therapy that improves vision. Its approval will soon be deliberated by the U.S. Food and Drug Administration.

Biotech October 10, 2017

The ACLU Wants To Make The Abortion Pill More Accessible To Women Who Need It

The American Civil Liberties Union filed a lawsuit against the Food and Drug Administration, as it looks to make the abortion pill more accessible to women. According to the ACLU, the FDA imposes 'onerous and medically unnecessary' restrictions over Mifeprex.

Medicine October 4, 2017

FDA Targets Lower Nicotine Levels To Combat Cigarette Addiction

U.S. Food and Drug Administration (FDA) chief Scott Gottlieb announced Friday new measures to lower nicotine levels in cigarettes and vaping products. The federal agency made the proposal for the first time to curb cigarette addiction.

Public Health July 31, 2017

Scientific Panel Seeks Harsher Strategy, Total Policy Overhaul To Solve Opioid Problem

An FDA-commissioned scientific panel recommends sweeping changes in doctors’ opiod prescription practices and health policy, in general, to stop the growing opioid epidemic in the United States. Here are the details on the new report.

Public Health July 14, 2017

Novartis CAR-T Cancer Therapy For Leukemia Gets Landmark Recommendation From FDA Panel

A new gene therapy developed by Novartis has received crucial recommendation from an FDA advisory panel on July 12. Experts believe the treatment’s approval will pave the way for new gene-based medicines.

Medicine July 13, 2017

Endo Pulls Opioid Opana ER From The Market After FDA Request

Endo Pharmaceuticals Inc. announced that they will voluntarily be removing Opana ER from the market as per the FDA's request. Despite this move, the company still believes in Opana ER's safety and efficacy.

Medicine July 8, 2017

FDA Approves Portola Drug Betrixaban For Blood Clot Prevention

The Food and Drug Administration has approved betrixaban for preventing blood clotting among patients with deep vein thrombosis. The oral treatment is the first extended duration treatment for hospitalized acutely ill patients.

Medicine June 23, 2017

Deer Antler Tea Recalled Over Botulism Contamination Fear In California

The California health department has warned consumers not to drink Deer Antler Tea products from U.S. Deer Antlers Exports and Imports Inc. out of concerns with Clostridium botulinum contamination. Here are the warnings and recall details.

Public Health May 9, 2017

FDA Approves New ALS Treatment Drug After 20 Years

The FDA approves an intravenous drug for treating amyotrophic lateral sclerosis (ALS) more than 20 years after the first drug was approved. The drug’s price will be steep in the United States.

Medicine May 6, 2017

FDA Approves Rydapt For Treatment Of Acute Myeloid Leukemia In Adult Patients

The FDA approved the Novartis AG's Rydapt on April 28. The drug is targeted toward AML patients and the FDA lists it for $22,500 for an average 42-day treatment.

Medicine May 1, 2017

Yellow Fever Vaccine In US To Run Out By Midsummer: CDC

CDC officials claimed that Yellow Fever vaccines in the United States would likely run out in July. However, the FDA authorized import of Stamaril, a yellow fever vaccine, which is licensed in Europe but not in the United States.

Public Health April 30, 2017

FDA Warns Use Of Kids Cough Syrup And Pain Meds That Contain Codeine

The U.S. Food and Drug Administration has issued a warning against the use of drugs containing codeine in children under the age of 12. Here’s why.

Public Health April 21, 2017

FDA Approves Vagus Nerve Therapy For Cluster Headaches

The Food and Drug Administration has approved the use of a handheld vagus nerve stimulation device in the treatment of cluster headaches. More than 350,000 people suffer from this extremely painful illness.

Public Health April 19, 2017

FDA OKs 23andMe At-Home Genetic Test Predicting Risk Of 10 Diseases

The U.S Food and Drug Administration granted permission to DNA company 23andMe to market personal genetic tests for 10 diseases. It will help consumers know genetic markers in advance and take precautions.

Medicine April 7, 2017

Conagra Recalls Hunt's Chili Kits Over Possible Salmonella Contamination

Conagra Brands Inc. issued a recall of a few of its Hunt’s Chili Kits batches due to probable Salmonella contamination. A supplier alerted the company to the probable existence of the bacterium inside the chili seasoning pack.

Public Health April 3, 2017

SoyNut Butter Maker Facility Closed After E.Coli Breakdown

FDA suspended the food facility registration of Dixie Dew Products after inspections revealed sanitary oversight during the manufacturing process. The SoyNut maker would not be able to sell or distribute any products made in the facility due to the suspension.

Public Health April 3, 2017

FDA Links Breast Implants To Rare Form Of Cancer, Confirms 9 Deaths

The FDA warned against breast implant-associated anaplastic large cell lymphoma (ALCL), a rare kind of non-Hodgkin’s lymphoma. It has so far led to nine deaths and a probe on the specific danger of breast augmentation surgery.

Public Health March 21, 2017

Houston Officials Consider Use Of Genetically Modified Mosquitoes To Fight Zika Virus

Officials of Harris County are considering the use of genetically modified mosquitoes to combat Zika virus and other deadly mosquito-borne diseases. The technology may fill in the gaps in existing methods to contain the spread of all mosquito-borne diseases.

Public Health March 21, 2017

FDA Approves Novartis Kisqali As Metastatic Breast Cancer Treatment

The new cancer drug developed by Novartis called Kisqali was approved by the FDA as a first-line treatment for metastatic breast cancer. The pill is intended as a combination treatment, designed for postmenopausal women who battle the condition.

Medicine March 15, 2017

Nail-Patella Syndrome: New Spotlight On 'No Kneecap' Disorder

The rare genetic disease nail-patella syndrome manifests as a lack of kneecaps, the improper development of nails, and other physical abnormalities. In most cases, the syndrome leads to kidney disease as well.

Public Health March 3, 2017

Intragastric Balloon: A New Anti-Obesity Treatment Minus The Surgery

An oral balloon pill that an obese person could conveniently swallow to help keep him full, lose weight, and finally break free from obesity. Sounds too good to be true? Not really.

Public Health March 3, 2017

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