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The Latest Breaking News from FDA

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

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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

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.

International Business Times UK

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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

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.

Marie Claire

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).

Benzinga

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…

The Conversation

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)

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

The Independent UK

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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.

Grocery Coupon Guide

8 Snack Labels That Mislead About Health Benefits

Walk down any grocery store snack aisle, and you’ll find products proudly displaying labels like “natural,” “low-fat,” or “made with real fruit.” These claims sound reassuring, but they don’t always tell the full story. In reality, some so-called healthy snacks are packed with sugar, sodium, or artificial additives that can…

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The Independent UK

Laura Loomer sets her sights on her next target to get the boot from the Trump administration

‘I’m not naive enough to think that the president is going to get rid of RFK, but I will say that … there are concerns about some of the staffing decisions over at HHS,’ Laura Loomer said this week.

The Conversation

COVID-19 vaccines for kids are mired in uncertainty amid conflicting federal guidance

It’s August, and parents and caregivers are frantically preparing their kids for a new school year by buying supplies, filling out forms and meeting teachers. This year, many parents also face a question that’s more complicated than usual: Should my child get an updated COVID-19 vaccine, and will I even…

Benzinga

Cognition Therapeutics Surges 30% Pre-Market After FDA Backs Phase 3 Trial Design For Alzheimer's Drug

Cognition Therapeutics Inc. (NASDAQ:CGTX) shares jumped 30% to $1.43 in pre-market trading on Wednesday after the company announced FDA confirmation of its Phase 3 trial design for Alzheimer’s drug Zervimesine (CT1812).

MarketBeat

Brutal 2025 for Sarepta—Analysts Still Call for 179% Upside

Per two Wall Street analysts, one of 2025's biggest losers could be set up for a stunning recovery. They see over 175% upside in Sarepta Therapeutics.

Benzinga

Why Is Liquidia Stock Trading Higher On Tuesday?

Liquidia Corporation (NASDAQ:LQDA) reported on Tuesday a second-quarter loss of 49 cents, missing the consensus of a loss of 43 cents.

Benzinga

FDA Approves Insmed's Drug As First Treatment For Type Of Chronic Lung Disease

The U.S. Food and Drug Administration (FDA) on Tuesday approved Insmed Incorporated’s (NASDAQ:INSM) Brinsupri (brensocatib 10 mg and 25 mg tablets). It is an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older.

Benzinga

CDC Shooting Linked To Suspect's COVID-19 Vaccine Beliefs, Former Staff Blame RFK Jr. Hostility Toward Agency

A group of former U.S. Centers for Disease Control and Prevention (CDC) employees are blaming HHS Secretary Robert F. Kennedy Jr. for vilifying the agency’s workforce through “his continuous lies about science and vaccine safety, which have fueled a climate of hostility and mistrust."

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