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FDA Approves Two-Drug Regimen For People that Are Undetectable

The approved drug, Juluca, is the first complete treatment regimen containing these two drugs to treat certain adults who are virologically suppressed.

U.S. FDA approves first two-drug HIV regimen in win for GSK

(Reuters) - The U.S. Food and Drug Administration has approved the first two-drug regimen to treat HIV, the virus that causes AIDS, aimed at lessening the side effect burden of current treatments that combine three or four medicines...

These Weight-Loss and Workout Supplements Contain Banned Ingredients Under Sneaky Names

New research suggests that supplements from four companies contain compounds that are either banned or not approved by the FDA.

FDA Approval Of Hemlibra, Gazyva A Big Positive For Roche

Roche’s hemophilia A therapy – Hemlibra – was recently approved by the FDA. This is a big win for Roche, as the drug’s estimated peak sales are touted to be as high as $5 billion.

Off Label Prescribing as Good as On Label

Once a drug has been approved for some use it may be legally prescribed for any use. New uses for old drugs are discovered quite often so off-label uses can be very different from FDA approved uses. Mitomycin, for example, was approved to treat stomach and pancreatic cancer but is used off-label in laser-eye surgery. Show More Summary

Should You Let Your Doctor Monitor Your Medication Intake?

A new pill has been approved by the U.S. Food & Drug Administration (FDA) that, when swallowed, notifies a monitoring device you wear that you actually took the medication. Sounds invasive and a gross violation of your privacy? Well, it would be. Except for the […]

First Electronic Device for Opioid Withdrawal Therapy Approved by FDA

The FDA has given a regulatory green light to the first device that reduces opioid withdrawal symptoms. The NSS-2 Bridge from Innovative Health Solutions, a Versailles, Indiana firm, is stuck to the skin behind the ear and relies on four electrodes that are attached around the ear. The electrodes are used to deliver electric current […]

Cincinnati children's research paves way for newly approved asthma drug

(Cincinnati Children's Hospital Medical Center) Thanks in part to nearly two decades of research at Cincinnati Children's Hospital Medical Center, the FDA has approved benralizumab, the first drug designed to specifically deplete eosinophils as a treatment for asthma.

FDA approves Ultragenyx drug for rare enzyme disorder

(Reuters) - The U.S. Food and Drug Administration approved on Wednesday a new treatment made by Ultragenyx Pharmaceutical Inc for a rare genetic disorder that can dramatically reduce life expectancy.

FDA Approves New Digital Sensor To Ensure "Patients With Mental Health Issues" Take Their Meds

Authored by Mac Slavo via, The Food and Drug Administration has just approved a new pill with a digital sensor in it. It will “ensure” that patients who suffer from mental health issues take their medicine when they are told. Show More Summary

The FDA Just Approved A Pill With Sensors In It For The First Time Ever

The era of digital pills is here. This week, for the first time ever, the US Food and Drug Administration approved a pill with sensors inside to inform doctors how often the drug was taken. More »      

FDA approves first smart pill that tracks drug regimen compliance from the inside

The FDA has approved the first smart pill for use in the United States. Called Abilify MyCite, the pill contains a drug and an ingestible sensor that is activated when it comes into contact with stomach fluid to detect when the pill has been taken. Show More Summary

FDA approves AstraZeneca's asthma drug

(Reuters) - Anglo-Swedish pharmaceutical firm AstraZeneca Plc on Tuesday said the U.S. Food and Drug Administration approved its drug benralizumab, as an add-on treatment for patients with severe asthma aged 12 years and older.

FDA Approves First Digital Pill That Can Track If You've Taken It

last weekNews : The Two-Way

Abilify MyCite is a tablet with an embedded sensor activated by fluid in the stomach. Although the drug's approval is a big step for digital medicine, there are concerns about privacy and cost.

Eat your medicine: The FDA has approved a digital pill for med tracking

The next time your doctor asks you to open up and say ahhhh, don’t be surprised if it’s so she can have you swallow a digital pill. The Food and Drug Administration has approved the first drug in the United States that comes with a digital ingestion tracking system. Show More Summary

FDA approves digital pill that alerts doctors when you take your medicine

The U.S. Food and Drug Administration has approved a digital pill for the first time today, paving the way for other forms of connected medicine that could shape the future of healthcare. The newly approved pill is called Abilify MyCite,...Show More Summary

A New Pill With a Digital Tracker Can Tell Your Doctor If You Swallow It

The Food and Drug Administration (FDA) issued a first-of-its-kind approval on Monday, approving the first drug in the United States with a digital ingestion tracking system. The new pill, called Abilify MyCite, contains an ingestible sensor that can help patients (and their doctors and caregivers) keep track of whether they are taking their medication as…

ABILIFY MYCITE, The First FDA Approved Digital Medicine That Tracks Its Own Ingestion

Proteus Digital Health, a Redwood City firm, and Otsuka Pharmaceutical of Tokyo, Japan won FDA approval for the world’s first digital pill. The ABILIFY MYCITE (aripiprazole) is a tablet with a tiny sensor embedded in its interior. After the tablet is swallowed and dissolved, the sensor meets the stomach juices, which activate it and allow […]

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