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The Latest Breaking News from FDA

GSK's Blood Cancer Drug Review Extended As FDA Seeks More Data

The US Food and Drug Administration (FDA) on Wednesday extended the review period for the Biologics License Application (BLA) for GSK plc’s (NYSE:GSK) Blenrep combinations for relapsed or refractory multiple myeloma patients who have received at least one prior line of therapy.

Benzinga

The Truth About “Organic”: 8 Common Kid Snacks With Dangerous Allergens

Image source: 123rf.com

Kids Ain't Cheap

15 Best Vagus Nerve Stimulation Devices in 2025

Stress and sleepless nights can wear anyone down

inkl

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Elevidys Halt Sparks Analyst Downgrades—Sarepta Races To Revise Label

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) announced Monday it will voluntarily and temporarily pause all U.S. shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, effective July 22.

Benzinga

What's Going On With Moderna Stock Wednesday?

Moderna Inc.’s (NASDAQ:MRNA) stock has surged approximately 37% in the last month but has dipped around 15% year to date.

Benzinga

Americans Are Turning To DIY Weight Loss Injections to Dodge $1,000+ Monthly Drug Costs

Demand for glucagon-like peptide-1 weight-loss drugs — such as Ozempic, Zepbound and Wegovy — coupled with limited insurance coverage has fueled a risky but growing “gray” market for purchasing active ingredients from China, Reuters reported recently.

Benzinga

Kennedy's mental health drug skepticism lands at FDA panel - Roll Call

Democrats have accused Robert Kennedy Jr. of making claims without scientific research to back them and say his claims are dangerous.

Roll Call

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Listeria Contamination Concerns Spark US Tuna Recall: How Serious Is Listeriosis?

Dozens of tuna salad products have been recalled from stores in seven US states due to possible listeria contamination, a bacteria that can lead to deadly infections like listeriosis.

International Business Times UK

EXCLUSIVE: Intelligent Bio Solutions' New Data Confirms Ability To Detect Trace Sweat Volumes At Ultra-Micro Level

Intelligent Bio Solutions Inc. (NASDAQ:INBS) on Wednesday announced the collection of new data that further reinforces the security and performance of its Intelligent Fingerprinting Drug Screening System, strengthening its FDA 510(k) submission.

Benzinga

Abivax Stock Skyrockets On Strong Data From Inflammatory Bowel Disorder Study

Abivax SA (NASDAQ:ABVX) stock is skyrocketing on Wednesday after the clinical-stage biotechnology company announced overwhelmingly positive topline results from its Phase 3 ABTECT-1 (Study 105) and ABTECT-2 (Study 106) 8-week induction trials for oral obefazimod (ABX464) in adult patients with moderately to severely active ulcerative colitis.

Benzinga

OFA Group Pops Nearly 70% After Hours As Bitcoin Strategy Comes In Focus

OFA Group (NASDAQ:OFAL) experienced an increase in its stock value after hours on Tuesday. The company’s stock value surged by 69.94% to $2.94.

Benzinga

More than Skin Deep: Exploring Rejuvaskin's Mission to Redefine Skin Health

For Chris Christenberry, CEO of Rejuvaskin, skin health goes beyond skincare buzzwords and marketing trends, but is rooted in medical necessity.

International Business Times

Sweetening soft drinks: What to know about sugar, high-fructose corn syrup and their alternatives

President Donald Trump teased the announcement last week, but Coca-Cola finally confirmed it Tuesday: a version of Coke’s trademark cola sweetened with cane sugar will be released in the U.S. this fall

The Independent UK

The FDA Just Approved Juul’s E-Cigarettes. Does That Make Altria Stock a Buy Here?

Altria was an earlier investor in Juul. Will its FDA approval be good news for the Altria’s NJOY brand?

Barchart

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Benzinga

FDA Names Biotech Veteran George Tidmarsh To Lead Drug Evaluation Division

The U.S. Food and Drug Administration appointed George F. Tidmarsh on Monday as director of the Center for Drug Evaluation and Research (CDER).

Benzinga

Drug Innovation At Risk By Trump Budget, Says Congressional Budget Office

According to a new U.S. Congressional Budget Office analysis, President Donald Trump’s 2026 budget plan proposes cuts to the National Institutes of Health that could significantly reduce the number of new drugs entering the market.

The Independent UK

Over 110,000 cases of popular ice cream affected by recall

The recalled products were sold in multiple flavors in 23 states

The Independent UK

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that have attracted attention from regulators

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news in one place.

100’s of premium titles.
One news app.

Benzinga

FDA Rejects Replimune's Blood Cancer Drug, Stock Sinks

Replimune Group, Inc. (NASDAQ:REPL) stock plunged on Tuesday after a U.S. Food and Drug Administration (FDA) update.

Benzinga

Sarepta Reverses Course, Pauses Elevidys Shipments Amid FDA Safety Review

The Independent UK

Two types of tuna recalled over listeria contamination fears

‘Anyone concerned about an injury or illness should contact a healthcare provider,’ the FDA said

Grocery Coupon Guide

10 Everyday Items That Were Removed for Legal Reasons

Ever go looking for a product you used to love—only to realize it quietly disappeared? Sometimes, these disappearances aren’t just because of declining sales or changing trends. Many banned everyday items have been pulled from the market due to lawsuits, safety concerns, or regulatory pressure. From kitchen tools to beauty…

Android Central

Ask Jerry: Why are some health features for wearables not available in the US?

Have a question about the tech in your life? If so, maybe we can get them answered!

Benzinga

Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets

On Friday, the U.S. Food and Drug Administration placed Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) investigational gene therapy clinical trials for limb girdle muscular dystrophy (LGMD) on a clinical hold.

MarketBeat

3 Bullish Biotech Stocks With Explosive Growth Trends

These small-cap biotech stocks offer high-reward potential with bullish momentum and key catalysts ahead in urology, autoimmune, and gene editing therapies

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