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The Latest Breaking News from FDA

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

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

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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

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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

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”.

Bangkok Post

FDA authorizes Juul to continue selling e-cigarettes

IN FULL

The Independent UK

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

The Guardian - US

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

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

Reason

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.

International Business Times

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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

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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…

Benzinga

Tempus AI Stock Is Rising Wednesday: What's Happening?

Tempus AI Inc (NASDAQ:TEM) shares are trading higher Wednesday after the company announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ejection fraction software.

Euronews

Trump administration is pushing for psychedelic therapy. Will it help or hamper the field?

US health secretary Robert F Kennedy Jr said he wants psychedelic therapies approved within a year, surprising even the staunchest supporters of the drugs.

The Independent UK

Will RFK Jr.'s push for psychedelic therapy help or hamper the emerging field?

Health Secretary Robert F

Reason

Fourth Circuit Rejects Claim that West Virginia Abortion Law Is Preempted

A mifepristone manufacturer is unsuccessful in evading West Virginia's prohibition on abortion, even when performed by medication.

Benzinga

GSK Seeks FDA Nod To Broaden RSV Vaccine For Younger At-Risk Adults

On Monday, the U.S. Food and Drug Administration (FDA) agreed to review GSK plc’s (NYSE:GSK) application to extend the indication of Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18-49 who are at increased risk.

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