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The Latest Breaking News from FDA

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

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

From analysis to the latest developments in health,
read the most diverse news in one place.

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

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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

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....

Saving Advice

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.

Benzinga

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

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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.

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news in one place.

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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.

Clever Dude

Are Chemical Sunscreens Safe? Here’s What the Latest Research Really Says

You’ve probably seen claims that chemical sunscreens are harmful—but what’s the real story behind those warnings? With buzz on social media and litigation around ingredients like oxybenzone, many wonder if they should switch. The latest science offers clarity: chemical filters are absorbed into the bloodstream—but current evidence doesn’t show this…

The Independent UK

Sarepta will resume gene therapy shipments after FDA review of recent patient death

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy

Benzinga

Sarepta Therapeutics Stock Soars After FDA Removes Hold On Elevidys For Some Patients

Sarepta Therapeutics Inc (NASDAQ:SRPT) shares were halted in extended trading Monday after the U.S. Food and Drug Administration (FDA) recommended the removal of a voluntary hold for Elevidys.

Benzinga

FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys

The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an 8-year-old boy who had received Elevidys, Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) gene therapy for Duchenne muscular dystrophy.

The Independent UK

Weight-loss jab Wegovy sees another prescription boost after ban on copycats

Novo CEO ousted in May, in place until successor named

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