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Tag: FDA

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

Ruth’s Pimento Spreads Recalled Over Listeria Risk

Ruth’s Salads has announced an expanded recall of pimento cheese products. In a food recall announcement, the FDA pointed to potential listeria contamination as the reason behind the recall.

Public Health February 10, 2017

Smokeless Tobacco Products Recalled As Sharp Metal Fragments Are Found Inside

U.S. Smokeless Tobacco Company has voluntarily recalled some smokeless tobacco products after sharp metal objects have been found in selected cans. The FDA too is pursuing a new rule that will limit a carcinogen content in such products.

Public Health February 2, 2017

Skin Cancer Cream Reportedly Kills 5 Dogs

The FDA has released a new advisory warning pet owners of reported dog deaths from the topical cancer drug fluorouracil, marketed under brand names such as Carac, Efudex, and Fluoroplex.

Medicine January 19, 2017

Holiday Twinkies Voluntarily Recalled Over Salmonella Concerns

Hostess voluntarily recalls its holiday-edition White Peppermint Twinkies over potential salmonella contamination, due to a confectionary coating on the cakes that contains recalled milk powder.

Public Health January 11, 2017

Bayer Seeks FDA Approval For Regorafenib As Liver Cancer Treatment

German drugmaker Bayer on Monday submitted an sNDA proposal to the FDA for the extension of its drug Regorafenib as a second-line treatment for liver cancer. The drug is currently used to treat colorectal cancer.

Medicine November 8, 2016

Prescription Testosterone, Other Steroid Drugs Product Labels Get New Warning From FDA

The U.S. Food and Drug administration is stepping up with warnings for prescription drugs that treat low testosterone. The abuse of the said drugs has been proven to be linked with heart-related and mental health problems, among others.

Medicine October 26, 2016

FDA Gives Merck Green Light To Market Keytruda Lung Cancer Drug

Merck's cancer drug Keytruda got the nod of U.S. regulators as a first-line drug for treating metastatic non-small cell lung cancer. For the pharmaceutical company, the FDA approval opens a big market for it.

Medicine October 26, 2016

FDA Issues Safety Warning For St. Jude Medical Implanted Defibrillators After Two Deaths Reported

The FDA has issued a safety warning for defibrillators created by St. Jude Medical. The warning was given after two patients died because of abnormal battery depletion caused by lithium clusters in their implanted defibrillators.

Public Health October 13, 2016

Theranos Closes Labs And Wellness Centers, Lays Off 340 Employees

Theranos announced that it is closing its labs and wellness centers in multiple states, and is laying-off 340 people in the process. The biotech company used to be seen as a promising startup, but the tide has changed.

Business Tech October 6, 2016

FDA Warns Against Hepatitis B Reactivation In Some Patients Taking Direct-Acting Hepatitis C Antivirals

The FDA warned against the potential risk of Hepatitis B virus reactivation in patients treated with direct-acting antiviral drugs for Hepatitis C. 'Boxed Warnings' about Hepatitis B reactivation risks on antiviral drug labels are now mandated.

Medicine October 5, 2016

FDA To Redefine ‘Healthy Food,’ Seeks Public Comment

The U.S. Food and Drug Administration is turning to the public for help in defining what is “healthy.” Guidelines were released decades ago and no longer meet recent public health recommendations.

Public Health September 29, 2016

FDA Cracks Down On Online E-Cigarette Sales, To Fine Stores Selling To Minors

The FDA is serious about keeping e-cigarettes off the hands of minors. The agency recently warned online retailers that fines will be imposed on those who will be selling e-cigarettes to underage buyers.

Public Health September 17, 2016

FDA Warns Women Against Results Of Ovarian Cancer Screening Tests

FDA issued a warning against the use of ovarian cancer screening tests such as the CA 125 test. The agency said that erroneous results may lead women to either forgo treatment or undergo unnecessary care.

Public Health September 8, 2016

FDA Bans Various Antibacterials From Consumer Soaps

Soapmakers were given a year to prove whether the antibacterials used in their products were effective, and since they failed to do so, the FDA has decided to issue a ban on 19 of the most commonly used antibacterials used in commercial soaps.

Public Health September 3, 2016

Roche Receives Emergency Use Authorization From FDA For LightMix Zika Test

Microcephaly is one of the brain defects prominently associated with the Zika virus. With Roche’s LightMix test, it will only take 2.5 hours to analyze up to 96 samples, helping speed up detection of the virus.

Public Health August 29, 2016

FDA Approves First Cognitive Screening Test For Head Injury Patients

More than 2 million people in the United States are rushed to the emergency room over head injuries. Now, health regulators have approved a screening test that may be helpful in treating head injury patients.

Biotech August 23, 2016

US Allows More Marijuana Research But Rejects Requests To Change Classification

The federal government on Thursday will announce the rejection of requests to change the classification of marijuana. At the same time, the government will expand a policy that may increase research on the substance.

Public Health August 11, 2016

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