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The Latest Breaking News from the US Food and Drug Administration

Gilead Reaches Settlement To Block Biktarvy Generics Until 2036

Gilead Sciences, Inc. (NASDAQ:GILD) on Monday entered into settlement agreements to resolve the patent litigations with Lupin Ltd., Cipla Ltd. and Laurus Labs Ltd., generic manufacturers that filed abbreviated new drug applications with the U.S. Food and Drug Administration to market generic versions of Biktarvy.

Benzinga

Mountain Dew, Gatorade and Cheetos to undergo makeover amid health fears

PepsiCo is looking at purple sweet potatoes and carrots to color drinks like Mountain Dew and Cherry 7Up

The Independent UK

‘IM GONNA GET SUPERPOWERS!!!’: Woman buys Great Value bag of shrimp from Walmart. Then she realizes it’s ‘radioactive’

Something strange is going on at Walmart. Recently, TikTok user Fae (@starsquishya) bought a bag of Walmart’s Great Value bag of shrimp. But what was meant to be a tasty snack became something else entirely after the US Food and Drug Administration (FDA) issued a warning about the popular food…

The Mary Sue

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Tonix Pharma's Drug Gets FDA Nod For Chronic Pain Condition, First New Therapy In Over 15 Years

On Friday, the U.S. Food and Drug Administration (FDA) approved Tonix Pharmaceuticals Holding Corp.’s (NASDAQ:TNXP) Tonmya (cyclobenzaprine HCl sublingual tablets) for fibromyalgia in adults.

Benzinga

Novartis' Investigational Drug Aces Two Pivotal Trials For Chronic Disease Impacting Tears, Saliva

Novartis AG (NYSE:NVS) on Monday released topline data from two Phase 3 trials, NEPTUNUS-1 and NEPTUNUS-2, evaluating ianalumab (VAY736) in adults with active Sjögren’s disease.

Benzinga

Vinay Prasad's Comeback To FDA Sparks Debate Over Regulatory Direction

In a stunning reversal, Dr. Vinay Prasad is returning to his role as director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), just days after his resignation.

Benzinga

8 Personal Care Products That Are Banned in Other Countries

Personal care products are part of daily life. You use them to clean, moisturize, and protect your body. But not every product on store shelves is safe everywhere. Some countries have banned certain personal care products because of health risks. These bans might surprise you, especially if you use these…

Clever Dude

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No clear answers on antidepressants in pregnancy

The US Food and Drug Administration recently convened a panel of experts to examine a sensitive and increasingly urgent question: should antidepressants be prescribed to women suffering from depression during pregnancy?

The Conversation

Married couple whose home was bursting with truckloads of illegal sex pills sentenced

Eduard Yusupov and Diana Fuzailov sold sexual enhancement products online via their company Love Potion, Inc., claiming them to be made from natural ingredients

The Independent UK

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys

The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments. The company’s response? A resounding “no,” igniting a major…

Benzinga

3-Parent Babies Born Healthy in the U.K.

The FDA blocked a similar successful treatment for mitochondrial disease a quarter of century ago.

Reason

US Authorizes Juul To Market Vaping Products

Juul Labs said Thursday that the US Food and Drug Administration had officially authorized the e-cigarette maker to market its vaping system and refill capsules in the United States.

International Business Times

Why Is Milestone Pharmaceuticals Stock Plunging On Friday?

Milestone Pharmaceuticals Inc. (NASDAQ:MIST) moved closer to potential FDA approval for its Cardamyst (etripamil) nasal spray, an investigational therapy for paroxysmal supraventricular tachycardia (PSVT), as the U.S. Food and Drug Administration (FDA) accepted the company’s response to prior issues.

Benzinga

US Approves Gilead's Twice-yearly Injection To Prevent HIV

The US Food and Drug Administration on Wednesday approved Gilead Sciences' twice-yearly injection to prevent HIV -- a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus.

International Business Times

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International Business Times UK

Diabetics at Risk: FDA Issues Highest-Level Recall on 2M Dexcom Devices Over 'Deadly Fault'

The FDA has recalled 2 million Dexcom glucose monitors due to a serious safety risk. Learn how diabetic patients should act immediately to protect their health.

Fortune

RFK Jr. will ‘end the war’ against alternative medicine at the FDA, from stem cell therapy to chelation

“If you want to take an experimental drug … you ought to be able to do that," said RFK Jr.

The Independent UK

Cardiologists are begging you to never practice this mid-morning habit

Reaching for the caffeine can backfire for some people

The Independent UK

US grocery chain recalls baby food pouches due to possible lead contamination

There is no safe level of exposure to lead for children, according to the U.S. Centers for Disease Control and Prevention

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Tom’s Guide

I wish I’d known about this freezer coin hack before — now I know if my food is safe to eat

Discover the coin hack that checks whether your freezer is keeping your food safe.

Medical Daily

RFK Jr. Is Giving Families 'False Hope' By Claiming He'll Figure Out Cause of Autism by September, Former FDA Vaccine Head Warns

Dr. Peter Marks criticized RFK Jr. for giving what he called "false hope" to families by claiming that the cause of autism will be identified by September.

Latin Times

RFK Jr. Is Giving Families 'False Hope' By Claiming He'll Figure Out Cause of Autism by September, Former FDA Vaccine Head Warns

Dr. Peter Marks criticized RFK Jr. for giving what he called "false hope" to families by claiming that the cause of autism will be identified by September.

The Conversation

Animal tranquilizers found in illegal opioids may suppress the lifesaving medication naloxone − and cause more overdose deaths

The animal tranquilizers xylazine and medetomidine are in approximately one-third of the illegal opioids available in the U.S., including fentanyl, heroin and oxycodone. Animal tranquilizers enhance the user’s euphoric high from opioids, particularly in those who have developed a tolerance to the opioid. But adding the tranquilizers to these already…

PetsRadar

Further cat food recalled amid bird flu concerns with more cats falling ill

The US Food and Drug Administration has recalled a further four products

Latin Times

Girl Scouts Asserts Cookies Are 'Trusted' After Joe Rogan Blasts the Treats as 'Toxic' Over Disputed Ingredients Report

The Girl Scouts responded accusations from Joe Rogan, alleging that cookies being sold by the youth organization contain toxic, harmful ingredients.

Fortune

RFK Jr. drinks raw milk—as do many others, spending up to $21 a gallon. What are the risks and benefits?

The dairy product has gotten lots of attention lately. Here's what we know about unpasteurized milk.

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