Posts filtered by tags: Fda[x]


 

Thermo Bags Brammer For $1.7B as Gene Therapy Deal Spree Continues

Thermo Fisher Scientific late Sunday evening agreed to buy Brammer Bio for $1.7 billion, yet another bet by a large biopharmaceutical organization on the future of gene therapy.Thermo (NYSE: TMO), a Waltham, MA, developer of lab equipment, made an all-cash offer for Cambridge, MA-based Brammer, a contract manufacturer of gene therapy delivery tools known as viral “vectors.”In a gene therapy procedure, these vectors—engineered viruses—are filled with genetic blueprints and infused into a patient...
Tags: Boston, Boston blog main, Boston top stories, National blog main, National top stories, New York blog main, New York top stories, Biogen, Biotech, Brammer Bio, Clinical Trials, Deals, FDA, Gene Therapy, Hemophilia, Johnson & Johnson


Wireless vulns in Medtronic's implanted defibrillators allow remote shocks, shutdown, denial-of-service battery attacks and data theft

Medtronic is the most notorious maker of insecure medical implants in America, with a long history of inserting computers into people's bodies with insecure wireless interfaces, toolchains and update paths, and nothing has changed. In a new CERT advisory -- scoring 9.3/10 for severity! -- we learn that remote attackers can hijack a Medtronic implanted defibrillator and administer potentially lethal shocks, shut down lifesaving features, and put the device into a high power-consumption mode ...
Tags: Post, FDA, Health, Ieds, Implants, Infosec, Medtronic, Security


Quitting Zyrtec May Lead to Intense Itching as a Withdrawal Symptom

Long-term users of the allergy medicine Zyrtec (cetirizine) sometimes report a rare but excruciating withdrawal syndrome with itching all over their body. Jessica Misener recently wrote about her experience quitting the drug at Medium, and reports that the FDA is looking into it. Read more...
Tags: Health, Medicine, Drugs, Fda, Medication, Lifehacks, Allergies, Side Effects, Zyrtec, Jessica Misener


Baby cough syrup is recalled after bacterial contamination

The FDA has recalled DG/health Naturals baby Cough Syrup + Mucus due to a bacterial contamination.
Tags: Cnn, Fda, DG


Will More Genetically Engineered Foods Be Approved Under The FDA's New Leadership?

With Gottlieb's departure from the FDA imminent, what should we expect from the FDA? How is it likely to regulate the still controversial genetically engineered foods?
Tags: Management, Fda, Gottlieb


Anastasia Beverly Hills Riviera Eyeshadow Palette Review & Swatches

Anastasia Beverly Hills Riviera Eyeshadow Palette ($45) is a new, limited edition Spring/Summer 2019 14 shade palette that contains bright pops of color combined with a few warmer neutral shades. I’ve become quite boring in my old age which means this eyeshadow palette wasn’t terribly appealing to me but I love Anastasia’s eyeshadow formula so much that I decided to purchase it and see if I could get some fun looks out of it for Spring and Summer. The palette is made in the USA however, it does...
Tags: Usa, US, Beauty, Fda, Cannes, Seychelles, Swatches, Anastasia, Eyeshadow, Makeup Reviews, Eyeshadow Palettes, Palm Palm, Macy s Ulta, Spring Collections 2019, Summer Collections 2019, Anastasia Beverly Hills Riviera


Why the new drug for postpartum depression won’t just treat it, it could destigmatize it.

When I heard that the FDA had approved the first-ever drug to treat postpartum depression, I was thrilled. Given how commonplace this serious mental health condition is, and how severe the impact can be on the entire family, I’ve always wished for a greater arsenal to help fight it and treat it. That’s where Zulresso […]
Tags: Shopping, Fda


United States: FDA And Pharmacy Weekly Digest - March 12 - BakerHostetler

FDA Commissioner Announces Resignation – Food and Drug Administration Commissioner Scott Gottlieb announced his resignation
Tags: News, United States, Food And Drug Administration, Fda, Scott Gottlieb


FDA approves brexanolone, first drug developed to treat postpartum depression

Approximately 1 in 9 women in the United States experiences symptoms of postpartum depression, according to the Centers for Disease Control and Prevention.
Tags: Health, United States, Fda


New postpartum depression drug won't help most mothers

It should be good news that the FDA has approved a specific drug, brexanolone, to treat mothers for postpartum depression, says Nicole Slaughter-Graham, but the reality isn't that simple.
Tags: Cnn, Fda, Nicole Slaughter Graham


FDA Approves Drug That Could Help Women With Postpartum Depression

The first drug for severe postpartum depression has been approved by the Food and Drug Administration. Thousands of women could benefit from the drug, but there are drawbacks, including a $35,000 price tag.
Tags: News, Food And Drug Administration, Fda


First postpartum depression drug gets FDA nod

Sage therapeutics’ Zulresso became the first drug approved for postpartum depression by the United States Food and Drugs Administration (FDA). This cause the shares of Sage to rise by over 5 percent on Tuesday this week.
Tags: Health, Fda, Sage, United States Food and Drugs Administration FDA, Zulresso


Jazz Pharma's sleep disorder treatment gets FDA nod

By Aakash B (Reuters) - The U.S. Food and Drug Administration approved Jazz Pharmaceuticals Plc's treatment for patients with a form of sleep disorder, the company said on Wednesday. The drug, solriamfetol, will treat excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The decision is a big win for the drugmaker whose patents covering its blockbuster narcolepsy drug, Xyrem, was declared invalid by a U.S. appeals court in July. (Reporting by Aakash Jagadee...
Tags: Science, Fda, Bengaluru, Reuters, U S Food and Drug Administration, Jazz Pharmaceuticals Plc, Jazz Pharma, Supriya Roy, Aakash Jagadeesh Babu


New Postpartum Drug Offers a Wholly Different Approach to Treating Depression

New mothers suffering from postpartum depression finally have a treatment approved specifically for them. It’s the second drug this month approved by the Food and Drug Administration to address depression in a dramatically different way. But the treatment won’t come without serious restrictions on its use, nor will it…Read more...
Tags: Science, Drugs, Mental Health, Depression, Food And Drug Administration, Fda, Postpartum Depression


New Postpartum Drug Is the Second Wholly Different Depression Treatment to be Approved This Month

New mothers suffering from postpartum depression finally have a treatment approved specifically for them. It’s the second drug this month approved by the Food and Drug Administration to address depression in a dramatically different way. But the treatment won’t come without serious restrictions on its use, nor will it…Read more...
Tags: Science, Drugs, Mental Health, Depression, Food And Drug Administration, Fda, Postpartum Depression


Board Question #92109: I am 43 years old. I have two children in ...

Q: Dear 100 Hour Board,I am 43 years old. I have two children in junior Primary. We are attempting to have a third child. My perinatologist has told me she feels my chances of developing pre-eclampsia for a third time are greater than 50%. After most of a year of thought and prayer, we have decided to risk the potential complications. We don't want a third child at any cost, but we don't want to pass up an opportunity out of fear that would truly multiply our family joy. I am making some lifesty...
Tags: Fda, Owlet Baby Care


I Suffered from Severe IBS for 18 Years till One Treatment Changed Everything

Nearly 16 million Americans suffer from IBS-D, or irritable bowel syndrome with diarrhea. Dawn Cobb suffered for almost two decades and thought surgery was her only hope—until a new FDA approved treatment changed everything.
Tags: Science, Fda, IBS, Dawn Cobb


San Francisco Wants to Ban All E-Cigarette Sales

The city of San Francisco has proposed a new ban on all e-cigarettes that haven’t been approved by the FDA from being sold in the city. The catch? No e-cigarette has been approved by the FDA.Read more...
Tags: Health, Science, Smoking, San Francisco, Food And Drug Administration, Fda, Nicotine, Vaping, E Cigarettes, Flavored E Cigarettes, Youth Vaping


FDA Approves First Drug To Treat Postpartum Depression

Postpartum depression affects nearly one in nine mothers after childbirth. Zulresso would be the first drug dedicated to treating the mental illness.
Tags: News, Fda, Zulresso


This Is How Plan B ACTUALLY Works

We’re all so damn busy trying to drink enough water, remember other people’s birthdays, fall in love, moisturize, and find personal fulfillment, it’s only natural that on occasion, things don’t go according to plan. The same is true of our sex lives.Fortunately, when sex is involved, the ® moniker is as apt as they come. In the realm of contraception, if your standard plan fails you (or is forgotten), it’s a go-to backup option for pregnancy prevention. No, it’s not an all-the-time solution...
Tags: Fashion, Music, Fda, Gupta, Ghodsi, Hannah Minn, Pari Ghodsi, June Gupta


The First FDA-Approved Drug For Postpartum Depression Is Here — But There's A Catch

The Food and Drug Administration (FDA) has approved the first drug to treat postpartum depression. According to the New York Times, on Tuesday, the FDA approved a drug called brexanolone to treat postpartum depression in adult women. The drug will be administered via injections into an IV and will be marketed under the name Zulresso.According to the Times, brexanolone — a synthetic form of the hormone allopregnanolone, a derivative of progesterone — begins to work to treat moderate to severe p...
Tags: Fashion, Music, Cdc, US, Cnn, New York Times, Fda, Times, Elizabeth Holmes, Food and Drug Administration FDA, Antoni, University of Rochester Medical Center, Sage Therapeutics, Center for Drug Evaluation and Research, Tiffany Farchione, Zulresso


FDA Approves Postpartum Depression Drug

For the first time, the U.S. Food and Drug Administration has approved medicine to treat postpartum depression.
Tags: News, Fda, U S Food and Drug Administration


FDA warns two breast implant makers for failure to comply with post-approval study requirements

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.
Tags: Health, Fda, U S Food and Drug Administration


FDA approves first drug for treatment of postpartum depression in adult women

The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous use for the treatment of postpartum depression in adult women. This is the first drug approved by the FDA specifically for PPD.
Tags: Health, Fda, U S Food and Drug Administration


Here are the 88 companies that launched at YC’s W19 Demo Day 2

Today was the second half of Y Combinator’s two-day Demo Day for its Winter 2019 class. Over 85 startups pitched on stage yesterday, and another huge batch launched today. Previously held at the Computer History Museum in Mountain View, this YC Demo Day instead took over a massive warehouse in San Francisco. Like yesterday’s pitches, today’s were split across two stages (“Pioneer” and “Mission”) running in parallel — so even if you were there, you couldn’t see everything alone. Here are all o...
Tags: Travel, TC, Facebook, Y Combinator, Texas, Craigslist, California, Stanford, Southeast Asia, India, Africa, Disney, US, San Francisco, Usda, Google Analytics


'Modern-day prohibition'? San Francisco looks to ban e-cigarette sales until FDA review

Seeking to curb teen vaping, San Francisco officials on Tuesday introduced legislation to ban the sale of electronic cigarettes until an FDA review.            [Author: USA TODAY]
Tags: Usa, News, San Francisco, Fda, Usa Today


FDA Approves First Drug Targeted At Treating Postpartum Depression

The 60-hour brexanolone infusion treatment is expected to be available starting in June.
Tags: News, Fda


FDA approves first postpartum depression drug. It works quickly but costs over $20K, report says

Brexanolone, sold as Zulresso, is delivered as a continuous IV infusion over 60 hours. It reportedly works quickly and costs $20,000 or more.            [Author: USA TODAY]
Tags: Usa, News, Fda, Usa Today, Brexanolone, Zulresso


J&J and Sientra get FDA warning letters over breast implants

The U.S. Food and Drug Administration has issued warning letters to Sientra Inc and a Johnson & Johnson unit for failing to comply with the post-approval study requirements for their breast implants. Last month, the FDA issued a statement warning doctors about a type of lymphoma linked to breast implants after receiving reports of the disease. The agency's letters, dated March 18, highlighted issues in the companies' post-approval studies, which included evaluating the long-term performance an...
Tags: News, Fda, U S Food and Drug Administration, Johnson Johnson, Sientra Inc