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The Latest Breaking News from FDA

FDA Lifts Rocket Pharmaceuticals Study Hold For Rare Disease Gene Therapy

Rocket Pharmaceuticals Inc. (NASDAQ:RCKT) stock is trading higher on Wednesday after the U.S. Food and Drug Administration (FDA) lifted the clinical hold on its pivotal Phase 2 trial of RP-A501 for Danon disease.

Benzinga

Walmart shrimp laced with radioactive material, FDA warns public as it can damage DNA

But Americans' reactions have so far been unexpectedly lighthearted.

We Got This Covered

Why Rocket Pharmaceuticals Shares Are Trading Higher By Over 15%; Here Are 20 Stocks Moving Premarket

Shares of Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT) rose sharply in pre-market trading after the company disclosed that the FDA has lifted the clinical hold on the pivotal Phase 2 trial of RP-A501 for the treatment of Danon disease.

Benzinga

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Two years on from Australia’s bold psychedelic experiment, here are our concerns

A small Australian trial that used psychedelic-assisted therapy to improve the mental health and wellbeing of terminally ill patients is in the news today.

The Conversation

Can Radioactive Shrimp Kill You? Walmart Seafood Poses Danger As FDA Issues 'Do Not Sell' Warning

FDA warns against Walmart's Great Value shrimp over possible cesium-137 contamination. Seafood recall alert with shrimp lot codes and safety details.

International Business Times UK

Walmart recalls Great Value frozen shrimp products

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The Independent UK

FDA recalls five types of cheese over contamination concerns

IN FULL

The Independent UK

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FDA recalls more bagged, frozen shrimp over possible radioactive cesium contamination

The FDA is warning consumers not to eat certain frozen shrimp products sold at Walmart after other products from the same company tested positive for a radioactive substance.

LiveScience

Walmart recalls shrimp over possible radioactive contamination

FDA announced that certain Great Value raw frozen shrimp sold at Walmart could be potentially contaminated with Cesium-137, a radioactive isotope

The Independent UK

Thousands of pounds of cheese recalled over possible Listeria contamination

The source was determined to be ‘from environmental contamination that migrated to food-contact areas of the production process’

The Independent UK

FDA Extends Decision Date On Regenxbio's Gene Therapy Into Next Year

The U.S. Food and Drug Administration (FDA) on Monday extended its review timeline for REGENXBIO Inc.’s (NASDAQ:RGNX) Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.

Benzinga

PTC Therapeutics Faces FDA Rejection On Rare Disease Treatment Over Efficacy Concerns

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on Tuesday related to PTC Therapeutics, Inc.‘s (NASDAQ:PTCT) New Drug Application (NDA) for vatiquinone for Friedreich’s ataxia.

Benzinga

10 Label Terms That Mean Nothing Legally

The front of a food package is a battlefield for your attention, and marketers use a powerful arsenal of unregulated buzzwords to win your trust. These terms are carefully chosen to make a product seem healthier, higher-quality, or more wholesome than it is. However, because these words have no official,…

Grocery Coupon Guide

FDA Cracks Down on Whipped Sunscreens, Citing Lack of Approval and Safety Concerns

FDA warns consumers to avoid whipped, mousse, and foam sunscreens due to safety and lack of approval.

Medical Daily

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Benzinga

Fabrinet, Adecoagro And Other Big Stocks Moving Lower In Tuesday's Pre-Market Session

U.S. stock futures were mixed this morning, with the SP 500 futures falling around 0.1% on Monday.

Benzinga

Why Is Soligenix Stock Soaring On Monday?

Soligenix, Inc. (NASDAQ:SNGX) stock is higher on Monday after the U.S. Food and Drug Administration granted orphan drug designation to dusquetide, the active ingredient in SGX945, for Behçet’s Disease.

Fortune

Novo Nordisk slashes price of Ozempic in half to $499 for cash-paying, eligible U.S. patients

The previous out-of-pocket price was nearly $1,000.

Benzinga

Novo Nordisk Surges On Wegovy Win, Eyes Bullish Rebound Near 52-Week Lows

Novo Nordisk A/S (NYSE:NVO) may have found a timely catalyst. From the lows of its 52-week trading range, the Danish drugmaker is showing signs that a bullish comeback might be on the horizon—driven by both regulatory approval momentum and technically solid market signals.

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Benzinga

BioXcel Therapeutics (BTAI) Stock Is Surging Monday: What's Going On?

BioXcel Therapeutics Inc (NASDAQ:BTAI) shares are trading higher. The AI biopharmaceutical company on Monday announced positive meeting comments from the U.S. Food and Drug Administration (FDA).

Benzinga

Tonix Pharma's Drug Gets FDA Nod For Chronic Pain Condition, First New Therapy In Over 15 Years

On Friday, the U.S. Food and Drug Administration (FDA) approved Tonix Pharmaceuticals Holding Corp.’s (NASDAQ:TNXP) Tonmya (cyclobenzaprine HCl sublingual tablets) for fibromyalgia in adults.

The Independent UK

FDA's new expert panels are rife with financial conflicts and fringe views

A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules and promoting fringe views about antidepressants and other products

Benzinga

Why Dayforce Shares Are Trading Higher By Around 21%; Here Are 20 Stocks Moving Premarket

Shares of Dayforce Inc (NYSE:DAY) rose sharply in pre-market trading.

Benzinga

Novo Nordisk's Wegovy Snags Conditional FDA Nod For Fatty Liver Disease

On Saturday, the U.S. Food and Drug Administration (FDA) approved an additional indication for Novo Nordisk A/S’ (NYSE:NVO) Wegovy (semaglutide 2.4 mg) based on a supplemental New Drug Application (sNDA) for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver fibrosis (consistent with stages F2 to F3…

International Business Times UK

Ozempic Lawsuit: Patients Claim Life-Threatening Side Effects As Safety Questions Put Zepbound In The Spotlight

Over 2,000 Ozempic and Zepbound lawsuits allege life-threatening side effects as FDA updates warnings and courts weigh evidence.

International Business Times UK

Florida Mum Suffers Miscarriage After Raw Milk 'Poisoning' – But Why Are So Many Still Drinking It?

A Florida mother claims raw milk caused her miscarriage amid outbreak tied to Keely Farms Dairy. Officials warn of risks for pregnant women and children.

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