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The Latest Breaking News from FDA

Celcius Energy Drink Lawsuit Coming? FDA Recalls Product For Traces Of 'Alcohol'

A vodka seltzer mix-up in Celsius cans prompts an FDA-backed recall and legal scrutiny, raising concerns about branding, safety, and supply chain accountability.

International Business Times UK

Celsius Energy Drink Cans Mislabeled With Vodka Triggers Recall And FDA Warning: What's Going On?

An unspecified number of cans labeled as Celsius Holdings Inc. (NASDAQ:CELH) energy drinks were accidentally filled with High Noon vodka seltzer before reaching stores, prompting a recall posted to the Food and Drug Administration's website.

Benzinga

Vinay Prasad vs the FDA: How One Doctor's Policies Collided with Politics and Cost Him His Job

Vinay Prasad resigns from the FDA after backlash over vaccine restrictions and gene therapy decisions. Political pressure cited in sudden departure.

International Business Times UK

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To prevent 'unintentional alcohol ingestion,' High Noon is recalling vodka seltzers mislabeled as Celsius energy drinks

High Noon withdraws, partner.

Fortune

FDA looking to make vapes less addictive as agency head claims 85% of those sold are ‘illegal’

FDA Commissioner Marty Makary warns ‘epidemic’ of e-cigarette use in high schools needs to be tackled

The Independent UK

What's Going On With Sarepta, Capricor And Other Gene Therapy Stocks On Wednesday?

In May, FDA Commissioner Marty Makary named Vinay Prasad the next director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER). Within three months, Prasad resigned.

Benzinga

FDA’s top vaccine official leaves post after less than four months

Trump administration gives no details about reason for departure of Vinay Prasad, but he had critics and had taken unusual actions

The Guardian - US

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GSK Lifts Outlook As Specialty Medicines, Vaccines Fuel Growth

British pharmaceutical giant GSK Plc (NYSE:GSK) shares rose on Wednesday after reporting second-quarter results that surpassed analyst expectations and led the company to raise its full-year 2025 guidance.

Benzinga

2 Growth Stocks Wall Street Predicts Will Soar 74% to 159%

With a strong pipeline, these two biotechs are poised for explosive growth.

Barchart

‘Never drinking Dr Pepper again’: Worker gets sick after moving to new line at Dr Pepper plant. Now she’s warning soda lovers

A woman says that she’s blowing the whistle on a Dr Pepper plant after claiming to have experienced several health issues as a consequence of working for the company.

The Mary Sue

VALÉB Announces the Upcoming Launch of Groundbreaking Advancement in Cervical Pre-Cancer Treatment

VALÉB, a breakthrough cervical treatment device founded by Dr. Dirk Coeman, offers a safer, smoke-free, and fertility-friendly alternative to traditional LEEP and cone biopsies. Expected to launch in 2027, this innovation may transform reproductive care worldwide.

International Business Times

How Neuromodulation is Reshaping the Treatment of Resistant Mental Health Disorders and Restoring Hope

Michigan Advanced Psychiatry pioneers FDA-approved neuromodulation therapies like TMS, IV ketamine, and Spravato to treat resistant mental health conditions, offering fast, effective alternatives for patients who haven't responded to traditional care.

International Business Times

1 Analyst Thinks This Former Pandemic Winner Could Surge 500% This Year

This risky biotech company faces significant challenges ahead. But it has already proven its worth and may be able to do so again.

Barchart

Up 215% YTD, Should You Grab This Growth Stock Before It’s Too Late?

If successful, Celcuity could emerge as one of the breakout biotech stars of 2025.

Barchart

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Saving Advice

These 7 Food Label Terms Are Meaningless, But Legally Allowed

You’ve seen them in every aisle: terms like “natural,” “made with whole grains,” or “no sugar added” plastered across food packages in bright, inviting fonts....

Benzinga

Sephience Gets FDA Approval, Now A Key Revenue Driver For PTC Therapeutics

The U.S. Food and Drug Administration approved on Monday PTC Therapeutics, Inc.’s (NASDAQ:PTCT) SEPHIENCE (sepiapterin) for children and adult patients with phenylketonuria (PKU).

Benzinga

FDA Lifts Safety Hold On Sarepta's Muscular Dystrophy Gene Therapy—Wall Street Cheers

As gene therapies continue to evolve as a promising frontier in medical treatment, regulatory scrutiny intensifies following safety concerns. Recent developments with Sarepta Therapeutics Inc (NASDAQ:SRPT) highlight the delicate balance between innovation and patient safety in the biopharmaceutical industry.

Benzinga

What's Going On With Eli Lilly Stock On Tuesday?

Eli Lilly and Co. (NYSE:LLY) stock is trading lower on Tuesday after its weight loss drug rival, Novo Nordisk A/S (NYSE:NVO), trimmed its 2025 financial outlook.

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The Independent UK

Single-serve coffee pods sold at Costco, Walmart and Target recalled for potential contamination

The recalled coffee pods were sold in 10-count boxes

The Independent UK

US health officials crack down on kratom-related products after complaints from supplement industry

U.S. health officials are cracking down on an opioid-like ingredient being added to drinks, supplements and other products

Benzinga

These Analysts Increase Their Forecasts On PTC Therapeutics

PTC Therapeutics, Inc. (NASDAQ:PTCT) announced it has gained FDA approval for SEPHIENCE on Monday.

Benzinga

Incyte Surges Past Expectations With Strong Q2, Boosts Guidance On Jakafi Demand

Incyte Corporation (NASDAQ:INCY) reported on Tuesday that its second-quarter revenue was $1.22 billion, up 16% year over year. The company beat the consensus of $1.15 billion.

Benzinga

AstraZeneca Q2 Sales Beat Estimates On Strong Cancer Drugs Revenues, Reaffirms 2025 Outlook

AstraZeneca Plc (NASDAQ:AZN) on Tuesday reported second-quarter 2025 sales of $14.46 billion, up 12% year over year (+11% at constant currency), marginally beating the consensus of $14.07 billion, driven by double-digit growth in oncology and biopharmaceuticals.

Benzinga

Ozempic And Wegovy Maker Cuts Outlook In Surprise Move, Picks New CEO

Novo Nordisk A/S (NYSE:NVO), the Danish pharmaceutical giant renowned for its weight-loss drug Wegovy and diabetes treatment Ozempic, experienced a significant downturn on Tuesday following the company’s decision to trim its 2025 financial outlook.

Benzinga

Sarepta Therapeutics Surges Over 40% In Tuesday Pre-Market: What's Going On?

Stock of Sarepta Therapeutics Inc. (NASDAQ:SRPT) surged 41.05% in Tuesday pre-market following the U.S. Food and Drug Administration’s (FDA) recommendation to lift the voluntary hold on Elevidys, Sarepta’s gene therapy for Duchenne Muscular Dystrophy.

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