Tag: FDA

New Drug To Boost Sex Drive In Women Gets FDA Approval

A new drug for hypoactive sexual desire disorder (HSDD) in premenopausal women has been approved by the U.S. FDA. HSDD is a female sexual desire disorder that has been recognized as a medical condition since the 1970s.

Medicine June 23, 2019

Some Experts Concerned Over FDA Fast-Track Cancer Treatment Approval Program

A new study evaluated new cancer treatments that received accelerated approval from the FDA. It found that out of 93 drugs in the program, only 19 were proven to extend the lives of patients who took them.

Public Health May 29, 2019

FDA Gives Thumbs Up To 2 New Extragenital Tests For Gonorrhea And Chlamydia

Two new devices that detect chlamydia and gonorrhea in the throat and rectum have received the approval of the FDA. These are the first devices to test for sexually transmitted infections using extragenital specimens.

Public Health May 25, 2019

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

Ambien, Other Insomnia Drugs Get FDA’s Strongest Warning For Their Troubling Side Effects

FDA gives insomnia drugs their strongest warning due to numerous cases of these medications causing serious side effects. In some recorded incidents, the patients have even experienced death or homicide.

Public Health May 2, 2019

Generic Anti-Overdose Nasal Spray Gets FDA Approval

The first generic naloxone nasal spray has been approved by the FDA. The move is a response to the increasing number of people who have died due to opioid overdose in the United States.

Public Health April 20, 2019

FDA Expands Lists Of Blood Pressure Drugs Recalled For Potentially Carcinogenic Ingredient

Torrent Pharmaceuticals has issued its fourth losartan recall since December after potentially carcinogenic impurities have been found in the high blood pressure medication. The FDA is advising patients to consult with pharmacists and physicians for alternatives.

Medicine April 20, 2019

FDA Warns Of Pre-owned, Unauthorized Medical Test Strips Sold Through Amazon, eBay, And Craigslist

Consumers should avoid buying and using pre-owned or unauthorized home use test strips through online marketplaces, according to the FDA. Many of these products might prove to be unsafe to use by patients.

Public Health April 20, 2019

FDA Added Sugar Label On Packed Food And Drinks May Prevent 1 Million Cases Of Cardiometabolic Diseases

A cost-effective study revealed that implementing the Food and Drug Administration's added sugar labeling policy could generate substantial health gains and cost savings. Among these gains include the reduction of diabetes and cardiovascular diseases.

Public Health April 16, 2019

FDA Issues Final Rule To Ensure Safety Of Hand Sanitizers

The FDA has ruled out 28 active ingredients found in hand sanitizers for evaluation under its OTC Drug Review. However, the agency is still reserving judgment on three other ingredients, including ethyl alcohol, until it completes its analysis.

Public Health April 12, 2019

Hawaii Could Be First US State To Completely Ban Flavored Vaping Products

Hawaii proposed a bill that will ban the sale of flavored e-cigarette liquids that are popular among young users. The bill aims to control the rising number of teens who vape.

Public Health April 1, 2019

FDA Publishes New Standards and Updated For Mammograms

For the first time in over 20 years, the FDA issued amendments to the national mammography standards. According to the federal agency, the proposed changes will improve and modernize breast cancer screening.

Public Health March 29, 2019

Breast Implant Safety Under Debate With New Cancer Risks

FDA reviews the safety risks of breast implants at a public hearing where multiple women spoke out against breast implant surgery. Breast implants have been linked to a number of health issues, including a rare type of cancer.

Medicine March 26, 2019

FDA Approves First Postpartum Depression Drug

The Food and Drug Administration has approved the use of the drug Zulresso in the treatment of postpartum depression among mothers. This marks the first time a specific medication will be used for treatment.

Medicine March 21, 2019

FDA Keeps Secret Database Of Medical Device-Related Injuries And Malfunctions, Report Claims

More than a million injuries and malfunctions have been recorded in a hidden database accessible only to the FDA. Under the alternative summary reporting program, companies obtained exemptions from making reports of their product malfunctions public.

Public Health March 20, 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 Approves First Immunotherapy Treatment For Breast Cancer

The FDA approved the first immunotherapy drug to treat breast cancer. The medication was specifically prescribed for patients with triple-negative breast cancer, which is the metastatic and advanced-stage disease.

Medicine March 9, 2019

Ketamine-Based Antidepression Nasal Spray Gets FDA Thumbs Up

The FDA announced on Tuesday that esketamine has been approved for people with treatment-resistant depression. The drug developed by Janssen Pharmaceuticals Inc. can offer quick relief from symptoms for patients living with the mood disorder.

Medicine March 6, 2019

Drug Manufacturer Points Finger At FDA Label Change Regulation As Cause Of Opioid Problem

A long-time drug manufacturer said that the FDA is partly to blame for the ongoing opioid crisis in the United States. A 2001 label change of Oxycontin, a powerful painkiller, gave more people access to the drug.

Public Health February 26, 2019

FDA Proposes New Rule To Ensure Safety, Effectiveness Of Sunscreen Products

One of the proposed changes would be to classify safe ingredients used in sunscreen products as GRASE. Only two of the 16 ingredients in sunscreens would be considered GRASE under the new proposal.

Public Health February 23, 2019

State Sanctioned Vaccine Exemptions Could Force Federal Hands To Move, Says FDA Chief

The FDA might take action if the states continue to allow parents to not vaccinate children despite the declaration of measles outbreaks in five states. There are currently 17 states that allow vaccine exemptions for philosophical reasons.

Public Health February 21, 2019

CDC Report Says 3.6 Million US Teens Vaped In 2018

A study by the CDC, FDA, and the National Cancer Institute found that the use of e-cigarettes among teens has increased significantly in 2018. Based on estimates, one in five high school students and one in 14 middle school students vape.

Space February 13, 2019

FDA Statement Warns Of Link Between Breast Implants And Cancer

The FDA said that the number of unique cases of anaplastic large cell lymphoma associated with breast implants increased to over 400 patients. The agency also noted that the disease is more common in textured breast implants.

Public Health February 9, 2019

American Lung Association Says The FDA Isn't Doing Enough To Keep E-Cigs Away From Children

American Lung Association issued a report that reviews the efforts of the federal government to restrict children's access to e-cigarettes. The FDA received a failing mark for allowing e-cigarette use among youths to rise in 2018.

Healthy Living/Wellness February 1, 2019

Problematic Medical Devices Force FDA To Change Rules

An explosive report forced the U.S. FDA to reconsider its application system for new medical devices. The overhaul was a response to thousands of injuries from medical devices based on older technology.

Public Health December 13, 2018

Researchers Looking Into Current Guidelines On Statin Usage

Should everyone take statin drugs? Researchers reviewed existing data from trials and surveys to weigh the side effects and benefits of the preventive drugs that claim to lower cholesterol.

Medicine December 4, 2018

FDA Recalls More Valsartan Blood Pressure Drugs Over Cancer Concerns

More valsartan blood pressure drugs were recalled due to the presence of NDEA, a chemical used as fuel. Teva Pharmaceuticals issued a voluntary recall of two of its valsartan combination drugs for fear it might cause cancer.

Medicine December 1, 2018

FDA Warns Against Honey Pacifiers Following 4 Infant Botulism Cases In Texas

The FDA is reminding parents not to feed honey to their infants, as their digestive systems are still immature. The warning comes after four infant botulism cases were reported in Texas.

Public Health November 17, 2018

FDA May Soon Crack Down On Menthol Cigarettes

A report said that the FDA might follow Canada and the European Union into banning traditional menthol cigarettes. The regulatory board might also crack down on flavored e-cigarette cartridges or pods.

Public Health November 12, 2018

Smoking In US At Record Low, Says CDC Report

A report by the FDA and the CDC revealed that only 14 percent of Americans smoke or consume tobacco products. The number is down from over 40 percent in the mid-60s.

Public Health November 9, 2018

FDA Approves Return Of Non-Prescription Asthma Inhaler After 7 Years

Seven years after it was taken off the market, asthma inhaler Primatene may now be purchased again for asthma relief. The new version no longer contains ozone-depleting CFC propellants.

Medicine November 9, 2018

FDA Approves New Opioid Despite Concerns Over Abuse And Misuse

The FDA just approved a powerful new opioid despite criticisms and concerns over its potential to contribute to the opioid crisis. Why was Dsuvia approved?

Medicine November 3, 2018

FDA Approves New Flu Treatment Drug

The U.S. FDA has approved Xofluza to relieve symptoms of flu. It is the first antiviral drug for flu to be approved by the public health body in the past 20 years.

Medicine October 25, 2018

FDA Warns Vape Company Over Vape Liquids With Erectile Dysfunction Drugs

The FDA issued a warning to an e-cigarette company regarding their products containing prescription drugs for erectile dysfunction. The products are considered misbranded under federal law.

Public Health October 15, 2018

Nearly 800 Dietary Supplements Tainted With Unapproved Ingredients Such As Viagra And Steroids

Nearly 800 dietary supplements were found to be tainted with hidden drug ingredients. Less than half of said products were recalled, and some are still available in the market.

Public Health October 13, 2018

FDA Expands Usage Of HPV Vaccine To Adults Aged 27 To 45

The FDA has approved the HPV vaccine Gardasil to be administered to men and women aged 27 to 45. The vaccine can protect individuals from nine types of HPV that cause certain cancers such as cervical, vaginal, vulvar, and anal.

Medicine October 7, 2018

MitraClip Heart Device Reduces Deaths Among Patients With Damaged Heart Valves

Researchers claimed that patients saw drastically improved symptoms after they had used the MitraClip during a two-year clinical trial. Fewer patients needed to be hospitalized because of severe heart failure.

Medicine September 25, 2018

Flea And Tick Medicine Can Cause Nerve Related Side Effects, Says FDA

The FDA issued a warning against a type of anti-flea and tick medicines that might cause adverse neurological issues. Dogs and cats that have taken these veterinary products experienced muscle tremors and seizures.

Medicine September 21, 2018

Over 2 Million Middle And High School Students In The US Have Vaped Marijuana, According To Study

A new study found that vaping marijuana is prevalent among children in middle school and high school in the United States. Up to 2 million children across the country have admitted to using e-cigarettes to smoke marijuana at least once.

Public Health September 19, 2018

FDA Findings Show Yet Another Impurity In Heart Drug Valsartan

The FDA has found NDEA, another known carcinogen, in some batches of valsartan drugs used for treating heart conditions and high blood pressure. The drugs have been added to the recalled list.

Medicine September 15, 2018

FDA Announces Approval For 2 New HIV Drugs

The U.S. Food and Drug Administration has approved two new drugs for patients diagnosed with HIV-1. Delstrigo and Pifeltro will be widely available across the country in the coming months.

Medicine September 3, 2018

E-Cigarette Companies Warned In May No Longer Selling In 'Kid-Friendly' Packaging: FDA

E-cigarette companies that were sent warning letters have already complied to the FDA and FTC's push. They no longer sell e-liquids that closely resemble the packaging for kid-friendly products.

Public Health August 25, 2018

Nationwide Recall Issued For 32 Children's Medicines For Possible 'Microbial Contamination'

King Bio issued a nationwide recall of over 30 types of its products over a potential microbial contamination. No illnesses have been reported, but the recall was set in place 'out of an abundance of caution.'

Public Health August 24, 2018

FDA Approves Device For OCD Treatment

Transcranial magnetic stimulation was previously approved by the FDA as a means to treat depression and headaches. Now, the FDA just approved a TMS device to help patients with OCD.

Medicine August 18, 2018

FDA Warns Veterinarians Of Pet Owners Potentially Using Animals To Get Opioid Prescription

The FDA is fighting on all fronts when it comes to the opioid epidemic. Veterinarians are called to partner with the agency in fighting the public health crisis.

Public Health August 16, 2018

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