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Why ‘approved’ medical devices may not be safe: A new addition to our toolkit

Yesterday we reported that 5 patient deaths linked to gastric weight loss balloon devices actually may be “the tip of the iceberg,” due to weak FDA regulations that don’t require mandatory reporting of complications from healthcare providers. As a result, no one really knows how many patients have died or suffered serious complications after undergoing […]

New commissioner says his time is going to food safety at FDA

New FDA Commissioner Scott Gottlieb claims food and tobacco issues are taking up a majority of his time. Maybe so, but there’s nothing on his public calendar to prove it. Drug approvals and the regulation of medical devices usually take up more of the FDA commissioners’ time than the food side of the house. But... Continue Reading

U.S. FDA approves GSK's three-in-one drug inhaler for COPD

(Reuters) - GlaxoSmithKline Plc and Innoviva Inc said on Monday the U.S. Food and Drug Administration has approved their triple drug inhaler for treatment of chronic obstructive pulmonary disease (COPD).

Medtronic’s Intellis Spinal Cord Neurostimulation System Released in U.S.

Medtronic won FDA approval and is releasing in the U.S. its Intellis spinal cord neurostimulation platform, which includes the world’s smallest fully implantable spinal cord neurostimulator. The system delivers both high-dose and low-dose...Show More Summary

Bayer cancer drug gets FDA approval to treat lymphoma

Pharmaceutical giant Bayer won swift U.S. regulatory approval to sell a drug that could help treat up to 30% of lymphoma patients.        

The FDA just approved the first direct competitor to a billion-dollar cancer drug

The FDA just approved a version of Avastin, a blockbuster chemotherapy made by Genentech that brought in $6.7 billion in sales in 2016. Why people are still getting sick 16 years after 9/11 A new study undermines Big Pharma's justification...Show More Summary

U.S. FDA approves Bayer drug to treat follicular lymphoma

(Reuters) - The U.S. Food and Drug Administration said on Thursday it has approved Bayer AG's treatment for follicular lymphoma, a cancer of the lymph system.

U.S. FDA approves biosimilar version of cancer drug Avastin

(Reuters) - The U.S. Food and Drug Administration said on Thursday it has approved Amgen Inc's biosimilar version of Roche Holding AG's cancer drug Avastin.

The FDA just approved the first direct competitor to a billion-dollar cancer drug (ROG.VX, AMGN)

The FDA just approved a version of Avastin, a blockbuster chemotherapy made by Genentech that brought in $6.7 billion in sales in 2016. The newly approved drug, made by Amgen, will go by the marketed name Mvasi. It's a type of medication...Show More Summary

ID Glide Lubricant Review (UPDATED 2017): Don’t Buy Before You Read This!

ID Glide Lubricant is a water based female lubricant that is meant to improve intimacy and sexual satisfaction. This can even be used on sex toys and they add it has been thoroughly tested. They have it approved by the FDA … Continue reading ?

'Impressed' FDA panel unanimously recommends GSK shingles vaccine

(Reuters) - A U.S. Food and Drug Administration advisory panel on Wednesday voted 11-0 that the safety and efficacy of GlaxoSmithKline's Shingrix shingles vaccine warrants approval for its use in adults aged 50 and over.

Type 2 Diabetes Drug Victoza FDA Approved to Treat Heart Disease

The FDA has approved the first type 2 diabetes drug for use in those who also have heart disease. Novo Nordisk’s Victoza has been approved for reducing the risk of a major adverse cardiovascular event like heart attack and stroke in adults with established heart disease and type 2 diabetes. The FDA based their decisions […]

FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program

6 days agoHealth : The Checkup

The Food and Drug Administration is changing the way it approves medicines known as “orphan drugs” after revelations that drugmakers may be abusing a law intended to help patients with rare diseases....

FDA Breaks New Ground With First Approved Gene Therapy for Cancer

When oncologist Dr. Carl June heard the Food and Drug Administration’s decision to bring the first gene therapy to market in the US, he pinched himself, hard. “It was so improbable that this would ever be a commercially approved therapy,” he said, voice breaking with emotion. June was referring to a revolutionary cancer therapy that […]

FDA Gives Okay For PTSD Sufferers To Start Ecstasy Trials

There is great news for the nearly 5.2 million people in the United States that suffer from Post-Traumatic Stress Disorder (PTSD). The F00d and Drug Administration (FDA) has given their approval for 3-4 methylenedioxymethamphetamine (MDMA), better known as the street drug ecstasy, to be used in Phase 3 trials for the treatment of PTSD. Show More Summary

Our Guide to Pre-Approval Access to Drugs For Both Doctors & Patients

By ALISON-BATEMAN HOUSE In April 2016, I published guidance, in the form of a mock case study, on how to access a drug before it has been approved by the FDA—what’s known as pre-approval (or expanded or compassionate) access. This is an updated version of that guidance, reflecting multiple important changes in the pre-approval landscape

PrEP Is Safe For Gay And Bi Teens, Study Reveals

last weekLGBT / Gay : NewNowNext

Teens face higher risk of HIV infection, but PrEP is currently only FDA approved for adults.

FDA Approves First Gene Therapy For Leukemia

The Food and Drug Administration on Wednesday announced what the agency calls a "historic action" -- the first approval of a cell-based gene therapy in the United States. The FDA approved Kymriah, which scientists refer to as a "living drug" because it involves using genetically modified immune cells from patients to attack their cancer. Show More Summary

FDA Approves America’s First Gene Therapy Treatment for Children with Leukemia

Acute lymphoblastic leukemia, or ALL, affects some 3,000 children and adults each year. Most of them do survive, but around 15 percent ultimately relapse, despite treatment and technology. Now there is a new treatment on the horizon – a gene therapy in which a person’s own blood cells are turned into a cancer-fighting army. Show More Summary

After Math: Business as Usual

It was a fairly uneventful week for the tech industry. Apple continued its quest to know everything about its customers. The FDA finally approved a genetic therapy for the first time Lyft spread its operation to 32 more states. And Juicero, purveyors of a $400 juice maker, shut down completely. Show More Summary

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