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The Latest Breaking News from FDA

FDA Extends Decision Date On Regenxbio's Gene Therapy Into Next Year

The U.S. Food and Drug Administration (FDA) on Monday extended its review timeline for REGENXBIO Inc.’s (NASDAQ:RGNX) Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.

Benzinga

PTC Therapeutics Faces FDA Rejection On Rare Disease Treatment Over Efficacy Concerns

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on Tuesday related to PTC Therapeutics, Inc.‘s (NASDAQ:PTCT) New Drug Application (NDA) for vatiquinone for Friedreich’s ataxia.

Benzinga

10 Label Terms That Mean Nothing Legally

The front of a food package is a battlefield for your attention, and marketers use a powerful arsenal of unregulated buzzwords to win your trust. These terms are carefully chosen to make a product seem healthier, higher-quality, or more wholesome than it is. However, because these words have no official,…

Grocery Coupon Guide

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FDA Cracks Down on Whipped Sunscreens, Citing Lack of Approval and Safety Concerns

FDA warns consumers to avoid whipped, mousse, and foam sunscreens due to safety and lack of approval.

Medical Daily

Fabrinet, Adecoagro And Other Big Stocks Moving Lower In Tuesday's Pre-Market Session

U.S. stock futures were mixed this morning, with the SP 500 futures falling around 0.1% on Monday.

Benzinga

Why Is Soligenix Stock Soaring On Monday?

Soligenix, Inc. (NASDAQ:SNGX) stock is higher on Monday after the U.S. Food and Drug Administration granted orphan drug designation to dusquetide, the active ingredient in SGX945, for Behçet’s Disease.

Benzinga

Novo Nordisk slashes price of Ozempic in half to $499 for cash-paying, eligible U.S. patients

The previous out-of-pocket price was nearly $1,000.

Fortune

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Novo Nordisk Surges On Wegovy Win, Eyes Bullish Rebound Near 52-Week Lows

Novo Nordisk A/S (NYSE:NVO) may have found a timely catalyst. From the lows of its 52-week trading range, the Danish drugmaker is showing signs that a bullish comeback might be on the horizon—driven by both regulatory approval momentum and technically solid market signals.

Benzinga

BioXcel Therapeutics (BTAI) Stock Is Surging Monday: What's Going On?

BioXcel Therapeutics Inc (NASDAQ:BTAI) shares are trading higher. The AI biopharmaceutical company on Monday announced positive meeting comments from the U.S. Food and Drug Administration (FDA).

Benzinga

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

FDA's new expert panels are rife with financial conflicts and fringe views

A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules and promoting fringe views about antidepressants and other products

The Independent UK

Why Dayforce Shares Are Trading Higher By Around 21%; Here Are 20 Stocks Moving Premarket

Shares of Dayforce Inc (NYSE:DAY) rose sharply in pre-market trading.

Benzinga

Novo Nordisk's Wegovy Snags Conditional FDA Nod For Fatty Liver Disease

On Saturday, the U.S. Food and Drug Administration (FDA) approved an additional indication for Novo Nordisk A/S’ (NYSE:NVO) Wegovy (semaglutide 2.4 mg) based on a supplemental New Drug Application (sNDA) for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3…

Benzinga

Ozempic Lawsuit: Patients Claim Life-Threatening Side Effects As Safety Questions Put Zepbound In The Spotlight

Over 2,000 Ozempic and Zepbound lawsuits allege life-threatening side effects as FDA updates warnings and courts weigh evidence.

International Business Times UK

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International Business Times UK

Florida Mum Suffers Miscarriage After Raw Milk 'Poisoning' – But Why Are So Many Still Drinking It?

A Florida mother claims raw milk caused her miscarriage amid outbreak tied to Keely Farms Dairy. Officials warn of risks for pregnant women and children.

Ultrahuman's smart ring adds "medical-grade" cycle tracking – for a price

The new Cycle & Ovulation Pro plug-in brings FDA-cleared fertility tech to the Ultrahuman Ring AIR

Marie Claire

It's About to Get a Lot Harder To Buy Your Favorite K-Beauty Products

Government regulations are coming for your Korean sheet masks and SPF.

Benzinga

Why Is Precigen Stock Surging On Friday?

On Friday, the U.S. Food and Drug Administration (FDA) approved Precigen Inc.’s (NASDAQ:PGEN) Papzimeos (zopapogene imadenovec-drba) for adult patients with recurrent respiratory papillomatosis (RRP).

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The Conversation

The growing fad of ‘microdosing’ mushrooms is leading to an uptick in poison control center calls and emergency room visits

Imagine you purchase a bag of gummies labeled nootropic – a term used to describe substances that claim to enhance mental ability and function, or “smart drugs.” However, within hours of consuming them, your heart starts racing, you’re nauseated and vomiting. Then you begin convulsing and have a seizure, resulting…

Whoop refuses to back down after FDA calls blood pressure feature a medical device

The battle over blood pressure tracking could reshape what wearables can legally do (in the US)

The Independent UK

FDA warns lead could be leaching into food from this cookware

Lead is toxic to people of any age or health status and higher exposure levels can lead to neurological changes

The Independent UK

Faith-based activist groups celebrate after Costco bails on selling abortion pill

‘They have nothing to gain and much to lose by becoming abortion dispensaries,’ Alliance Defending Freedom Legal Counsel Michael Ross said

Benzinga

What's Going On With Tonix Pharmaceuticals (TNXP) Stock?

Shares of Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) have rallied 30% over the past five sessions, though are marginally lower Thursday afternoon, as investors anticipate a key catalyst for the company.

Grocery Coupon Guide

7 Products Pulled for Undisclosed Ingredients

When a food company recalls a product, it is often because of a serious and potentially life-threatening mistake: the presence of an undisclosed ingredient. This usually happens when a major allergen, like nuts or dairy, is accidentally introduced into a product that is not supposed to contain it. For people…

Android Central

Whoop stands firm against FDA pressure over Blood Pressure insights tool

Whoop and the FDA clashed in recent issues over the former's BPI tool on its MG fitness band.

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