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The Latest Breaking News from FDA

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

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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

Nanoleaf expands its wellness range with new LED skincare gadgets

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

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.

Benzinga

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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

The Guardian - UK

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

MarketBeat

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

The Independent UK

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.

Tom’s Guide

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.

MarketBeat

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.

LiveScience

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

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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…

The Guardian - US

US health officials to revisit vaccine policies using anti-vax tactics, experts warn

Data public health experts say is worrisome will reportedly be presented to ACIP later this week before vote on shots

The Independent UK

FDA takes aim at Hims and other telehealth services in drug advertising blitz

The Trump administration has issued its first warnings to online services that offer unofficial versions of popular drugs like the blockbuster obesity treatment Wegovy

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Benzinga

Moderna Reports 8-Fold Jump In Antibodies With Updated Spikevax

Moderna Inc. (NASDAQ:MRNA) on Tuesday released preliminary immunogenicity data for the 2025-2026 formula of Spikevax, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19.

Benzinga

Adial Pharmaceuticals Highlights Favorable Comments From FDA Meeting For Lead Program In Alcohol Use Disorder

Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) on Tuesday received the final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) held in July.

International Business Times UK

What Is TikTok's Benadryl Challenge? Teen Almost Dies After Attempting Viral Trend

TikTok's Benadryl Challenge resurfaces after a teen's near-death overdose. FDA and doctors warn of severe health risks from the dangerous trend.

Benzinga

EXCLUSIVE: Scienture Secures PBM-Led Rebate Agreement To Position Hypertension Drug For Rapid Adoption In US Market

Scienture Holdings, Inc. (NASDAQ:SCNX) on Tuesday announced that it has formalized a commercial Pharmacy Benefit Manager (PBM) led Group Purchasing Organization (GPO) rebate agreement, advancing the process of securing formulary access with health plans covering more than 100 million lives for Arbli (losartan potassium) Oral Suspension, 10 mg/mL.

Kiplinger

Confused About the New COVID Vaccine and Medicare? What You Need to Know

Getting the new COVID-19 vaccine covered by Medicare isn't as easy this year as it was in the past. Here's what you need to know before you take a trip to your pharmacy.

Benzinga

FDA Expands Krystal Biotech Vyjuvek's Label Allowing Newborns Access To Gene Therapy For Blistering Skin

The U.S. Food and Drug Administration (FDA) on Monday approved Krystal Biotech, Inc.’s (NASDAQ:KRYS) label update for Vyjuvek (beremagene geperpavec-svdt).

Benzinga

ATyr Pharma Stock Sinks, Plans FDA Review After Mixed Phase 3 Results

Biotech firm aTyr Pharma Inc. (NASDAQ:ATYR) plummeted over 81% at last check on Monday, with a session volume of 34.7 million compared to the average volume of 4.83 million as per data from Benzinga Pro.

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