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The Latest Breaking News from FDA

FDA Clears Merck's One-Minute Cancer Shot

The U.S. Food and Drug Administration (FDA) on Friday approved Merck Co. Inc.’s (NYSE:MRK) Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for Keytruda.

Benzinga

FDA Delays Key Sanofi Multiple Sclerosis Drug Decision

On Monday, the U.S. Food and Drug Administration (FDA) extended the review date for Sanofi SA’s (NASDAQ:SNY) new drug application (NDA) of tolebrutinib for non-relapsing, secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients.

Benzinga

Could This Be the Cure?

For decades, a New York writer struggled to understand why she felt so stuck. It wasn't until she tried MDMA —and finally processed a dark episode from her past—that she got her answer.

Marie Claire

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Trump to Discuss New Autism Findings After Hinting At Major Discovery During Kirk Memorial

US President Trump may address autism findings, Tylenol risks during pregnancy, and potential treatments including leucovorin in a new briefing.

Medical Daily

Trump Administration To Unveil Tylenol-Autism Review, Tout This Drug As Potential Treatment: Report

The Trump administration is expected to unveil new efforts on Monday examining whether one widely used drug may be linked to autism and whether another could help treat it, according to people familiar with the plans who spoke to The Washington Post on condition of anonymity because the announcement was…

Benzinga

Trump Autism Update: US President Set to Discuss Autism Findings, Potential Tylenol Connection and Cure Options

US President Trump may address autism findings, Tylenol risks during pregnancy, and potential treatments including leucovorin in a new briefing.

International Business Times UK

Costco recalls popular ready-to-eat item over possible listeria contamination

The affected product was sold in 32 states

The Independent UK

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I used medication to overcome alcohol addiction. I've built my business on it

AA members had a lot to say about my experience with naltrexone, which is safe, effective, FDA-approved and not addictive.

Fortune

Medtronic's New Implant Could Transform Bladder Control Treatment

Innovative medical technologies are transforming healthcare by tackling chronic conditions that affect millions, offering hope and improved quality of life. The Food and Drug Administration (FDA) approved Medtronic plc’s (NYSE:MDT) Altaviva device on Friday.

Benzinga

FDA Expands Incyte's Opzelura Approval To Treat Atopic Dermatitis In Children

The U.S. Food and Drug Administration (FDA) on Thursday approved Incyte Corporation’s (NASDAQ:INCY) announced Opzelura (ruxolitinib) cream 1.5% for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription…

Benzinga

This AI Stock Has More Than Doubled in 2025. Is It a Buy?

After a remarkable triple-digit surge so far in 2025, is now the time to buy the shares of this AI stock?

Barchart

Eli Lilly’s Oral GLP-1 Breakthrough Could Change Everything

Eli Lilly stock rises on FDA fast-track hopes for its oral GLP-1 obesity drug and $27B U.S. manufacturing expansion; it's a tough trade but solid long-term hold

MarketBeat

Hims & Hers, Eli Lilly, Novo Nordisk Face FDA Scrutiny: What It Means For Weight-Loss ETFs

The U.S. Food and Drug Administration’s recent enforcement action against drug promotion is sending ETFs with exposure to weight-loss treatment manufacturers into question.

Benzinga

Baby food pouches part of latest food recall due to possible lead contamination

Pouches were sold at Walgreens and independent stores in the U.S. South region

The Independent UK

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Nanoleaf expands its wellness range with new LED skincare gadgets

They follow the brand's first-ever LED face mask from earlier this year

Benzinga

Short Report Alleges Dexcom Sold Faulty G7 Device Cited By FDA

Hunterbrook Media released a short report on diabetes-focused DexCom Inc. (NASDAQ:DXCM), citing that the company sold the "adulterated" device.

The Guardian - UK

Novo Nordisk shares climb after positive anti-obesity pill results

Danish drugmaker jumps by about £9bn as trial shows ‘significant weight loss’ with tablet version of Wegovy

MarketBeat

Biotech Breakouts: 3 Stocks With Massive Upside Potential

Biotech stocks are highly volatile; however, these biotech stocks have key trial results this fall that could spark sharp moves and long-term growth potential

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The Independent UK

FDA proposes ban on Orange B, a food dye not used for decades

The U.S. Food and Drug Administration is proposing to remove the food dye Orange B from the U.S. food supply

Tom’s Guide

FDA warns that imported cookware could be leaching lead into your food — check for these brands now

FDA alert: Check your cupboards for these pans — they may leach lead into food.

MarketBeat

Rezolute Stock: FDA Fast Track Fuels 2025 Breakout

Rezolute, Inc. is on track for its lead candidate to hit blockbuster status, but there are still risks and hurdles to overcome.

LiveScience

Science history: A tragic gene therapy death that stalled the field for a decade — Sept. 17, 1999

Sept. 17, 1999: Jesse Gelsinger died after receiving a gene therapy treatment to treat a liver disease. The death sparked an investigation and caution around gene therapy, which ultimately stalled the field for years.

Benzinga

FDA Flags Eli Lilly's Weight-Loss Drug Video For Misleading Claims

The U.S. Food and Drug Administration (FDA) has determined that a promotional video featuring Zepbound and Mounjaro (tirzepatide), both produced by Eli Lilly And Co. (NYSE:LLY), is false or misleading.

Benzinga

Hims & Hers Scrutinized For Marketing Its Product As Similar To Ozempic, Wegovy

Hims Hers Health Inc. (NYSE:HIMS) stock is trading lower on Tuesday. The U.S. Food and Drug Administration (FDA) issued a warning letter to Hims Hers Health, dated Sept. 9, addressed to the company’s CEO, Andrew Dudum.

The Conversation

Enhanced Games athletes can dope to compete for US$1 million prizes. But at what cost to sport?

Olympic swimmer Ben Proud has become the first British athlete to join the Enhanced Games – a controversial new event that allows athletes from all over the world to compete using performance-enhancing drugs. The prize money on offer can hit US$1 million (£730,000). But the swimmer, who won a silver…

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