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The Latest Breaking News from FDA

Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys

The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments. The company’s response? A resounding “no,” igniting a major…

Benzinga

10 Food Additives That Weren’t Allowed Until Recently

Food additives are everywhere. They keep our snacks fresh, make colors pop, and help foods taste better. But not every additive you see on a label today was always allowed. Some of these ingredients were banned or restricted for years. Now, after new research or changes in regulations, they’re showing…

Grocery Coupon Guide

Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths

Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy

The Independent UK

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9 “Doctor Recommended” Products That Were Pulled Without Headlines

In an age where trust in experts means everything, the phrase “doctor recommended” has long been a golden ticket to consumer confidence. Whether seen on TV commercials, drugstore shelves, or online ads, the medical seal of approval can sway even the most skeptical buyers. But not every product endorsed by…

Everybody Loves Your Money

10 Foods That Are Slowly Being Banned Around the Country

Food is more than sustenance. It’s culture, comfort, and tradition. But across the United States, some familiar items are quietly disappearing from store shelves and...

Saving Advice

6 Snacks From Childhood That Would Be Pulled Today

Childhood snacks hold a special place in our memories. Many of us remember the excitement of opening a lunchbox to find a treat that was sweet, salty, or just plain fun. But times have changed. Food safety rules are stricter. Nutrition guidelines are tougher. Some snacks that were once everywhere…

Grocery Coupon Guide

Health experts raise alarm over RFK Jr’s ‘war on science’ amid mass firings and budget cuts

Experts warn that the dangerous ideologically driven cuts at HHS will have long-term consequences for healthcare

The Guardian - US

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CBO finds health agency cuts would result in fewer new drugs - Roll Call

Potential NIH and FDA cuts could lower the number of new drugs that come to market in the next three decades, according to a CBO analysis.

Roll Call

The Vaping Giant That Almost Died: JUUL's Shocking FDA Reversal

In a significant reversal and a major boost for the embattled vaping company, the U.S. Food and Drug Administration (FDA) on Thursday authorized the marketing of five JUUL Labs Inc. e-cigarette products, including the JUUL device and its Virginia Tobacco and Menthol flavored JUULpods in both 3% and 5% nicotine…

Benzinga

Sarepta's Setback Deepens With Another Gene Therapy Fatality

Sarepta Therapeutics (NASDAQ:SRPT) shares plummeted on Friday following reports of a third patient death linked to its gene therapy pipeline this year, further clouding investor confidence despite the company’s recent efforts to provide clarity on its restructuring and FDA label plans.

Benzinga

10 Gas Station Foods That Are Linked to Health Warnings

Gas stations offer quick, convenient food options for people on the go, but that convenience often comes at a steep nutritional price. Many of the most popular gas station snacks and meals are ultra-processed and loaded with ingredients that health organizations warn against. These foods frequently contain excessive sodium, unhealthy…

Grocery Coupon Guide

Sarepta Therapeutics Stock Plunges Over 30% In Friday Pre-Market: What's Going On

Shares of Sarepta Therapeutics (NASDAQ:SRPT) plunged over 30% in Friday pre-market after a clinical trial participant died following treatment with a gene therapy, marking the third death linked to the company’s experimental treatments.

Benzinga

GSK's Blood Cancer Drug Faces US Setback Due To FDA Panel's Eye Safety Warning

The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s (NYSE:GSK) Blenrep (belantamab mafodotin-blmf) combinations.

Benzinga

Brainstorm Cell Therapeutics Crashes 42% After Voluntary Nasdaq Delisting Announcement

BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) shares crashed 42.74% to $0.67 in after-hours trading on Friday after the company announced its voluntary delisting from the Nasdaq Capital Market.

Benzinga

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Bangkok Post

Thailand cracks down on ‘zombie pods’ drug

Thai authorities are tightening restrictions on the drug etomidate to curb its use in potentially deadly vape products known as “zombie pods”.

The Independent UK

FDA authorizes Juul to continue selling e-cigarettes

IN FULL

The Guardian - US

Florida supreme court upholds congressional map that weakens Black voters’ influence

Ruling is a win for Republicans, who anticipate losing US House seats in next year’s midterm elections

Reason

3-Parent Babies Born Healthy in the U.K.

The FDA blocked a similar successful treatment for mitochondrial disease a quarter of century ago.

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International Business Times

US Authorizes Juul To Market Vaping Products

Juul Labs said Thursday that the US Food and Drug Administration had officially authorized the e-cigarette maker to market its vaping system and refill capsules in the United States.

The Independent UK

Juul will be allowed to sell e-cigarettes ending long fight over flavored tobacco on store shelves

The FDA ruled that Juul’s studies show its e-cigarettes are less harmful for adult smokers, who can benefit from switching to vapes from cigarettes

Benzinga

Sarepta Therapeutics' Reorganization Boosts Investor Confidence

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) stock is trading higher on Thursday after the company issued an after-hours update on ongoing label expansion efforts for Elevidys, its approved gene therapy for Duchenne muscular dystrophy.

The Independent UK

Juul can continue selling its tobacco and menthol e-cigarettes, FDA says

Federal health officials will allow Juul to keep selling its electronic cigarettes

The Independent UK

The deodorant was available at Walmart for $21 for a pack of three

Benzinga

FDA Lifts Pause On Kezar's Liver Drug Trial—Next Stop Lupus Study

The Division of Hepatology and Nutrition of the U.S. Food and Drug Administration lifted the partial clinical hold on Kezar Life Sciences Inc.‘s (NASDAQ:KZR) completed PORTOLA Phase 2a trial evaluating zetomipzomib in autoimmune hepatitis (AIH).

Benzinga

Big Bucks For Better Barks: Gallant Lands $18M To Bring Game-Changing Stem Cell Therapies To Pets

San Diego biotech startup Gallant just raised $18 million in a Series B financing round, furthering its quest to deliver the first ready-to-use stem cell therapy through conditional U.S. Food and Drug Administration approval. But the company isn't directing those funds toward the treatment of sick humans. Rather, it's wants…

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