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The Latest Breaking News from Food and Drug Administration

Why Heartbeam Shares Are Trading Higher By Around 43%; Here Are 20 Stocks Moving Premarket

Shares of Heartbeam Inc (NASDAQ:BEAT) rose sharply in pre-market trading after announcing its regulatory strategy following the Food and Drug Administration’s Not Substantially Equivalent (NSE) decision on its 12-lead Electrocardiogram Synthesis Software.

Benzinga

FDA Unveils First Experimental Drugs Under Fast-Track Voucher Plan To Cut Drug Review Times

The Food and Drug Administration announced on Thursday the first round of experimental drugs to be included in a priority voucher program. This FDA initiative is designed to expedite drug review processes for products that align with critical U.S. national health priorities, reducing review times from 10 to 12 months…

Benzinga

FDA Adds New Warning For Johnson & Johnson's Cancer Cell Therapy

The Food and Drug Administration (FDA) has updated safety labeling for Johnson Johnson's (NYSE:JNJ) Carvykti after receiving reports of immune effector cell-associated enterocolitis (IEC-EC)—a rare but serious complication seen in both clinical trials and postmarketing data.

Benzinga

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FDA Expands Use Of Regeneron's Evkeeza To Infants With Rare Cholesterol Disorder

The U.S. Food and Drug Administration (FDA) on Friday approved Regeneron Pharmaceuticals, Inc.’s (NASDAQ: REGN) Evkeeza (evinacumab-dgnb) ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia (HoFH).

Benzinga

Ousted FDA vaccine chief Vinay Prasad is returning to the agency

A Food and Drug Administration official who stepped down less than two weeks ago is getting his job back as the agency’s top vaccine regulator

The Independent UK

Boston Scientific Reports 16 Deaths Linked To Defibrillator Lead Issue

The Food and Drug Administration (FDA) said on Wednesday it is monitoring a potential safety issue involving Boston Scientific Corporation’s (NYSE:BSX) ENDOTAK RELIANCE defibrillation leads, following a letter from the company alerting healthcare providers of possible reduced shock efficacy.

Benzinga

FDA Sounds Alarm On Nationwide Butter Recall: Upgrades Risk Over Allergen Warning

The Food and Drug Administration has heightened concerns over a nationwide butter recall, escalating the risk level after discovering the presence of an undeclared major allergen.

Benzinga

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Celsius Energy Drink Cans Mislabeled With Vodka Triggers Recall And FDA Warning: What's Going On?

An unspecified number of cans labeled as Celsius Holdings Inc. (NASDAQ:CELH) energy drinks were accidentally filled with High Noon vodka seltzer before reaching stores, prompting a recall posted to the Food and Drug Administration's website.

Benzinga

Congress Sounds Alarm Over Illegal Weight-Loss Drug Imports From China

In a letter to the U.S. Food and Drug Administration (FDA) Commissioner Marty Makary on Friday, over 80 bipartisan members asked the agency to stop counterfeit and copycat versions of GLP-1 drugs like Novo Nordisk A/S’ (NYSE:NVO) Wegovy (semaglutide) and Eli Lilly and Co.’s (NYSE:LLY) Zepbound from flooding the market.

Benzinga

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

Does Australia really take too long to approve medicines, as the US says?

Australia’s drug approval system is under fire, with critics in the United States claiming it is too slow to approve life-saving medicines.

The Conversation

‘Gas station heroin’: the drug sold as a dietary supplement that’s linked to overdoses and deaths

The US Food and Drug Administration (FDA) has issued an urgent warning about tianeptine – a substance marketed as a dietary supplement but known on the street as “gas station heroin”.

The Conversation

Disposable e-cigarettes are more toxic than traditional cigarettes, researchers say

Lead and other harmful metals linked to cancer were found in disposable e-cigarettes

The Independent UK

US approves twice-yearly injection for HIV prevention – what you need to know about lenacapavir

The US Food and Drug Administration (FDA) has approved lenacapavir, an injectable drug that offers long-lasting protection against HIV infection. Administered once every six months, this new treatment marks a major advancement in expanding prevention options for people at risk of HIV infection.

The Conversation

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The Independent UK

Supreme court widens court options for vaping companies pushing back against FDA rules

The Supreme Court is siding with e-cigarette companies in a ruling that'll make it easier to sue over Food and Drug Administration decisions blocking their products from the multibillion-dollar vaping market

The Independent UK

FDA to offer faster drug reviews to companies promoting 'national priorities'

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump administration priorities for Americans' health

The Independent UK

Kraft Heinz pulling certain artificial dyes from its US products in 2027

Kraft Heinz will be pulling certain artificial dyes from its U.S. products starting in 2027 and will no longer roll out new products with the dyes

Bangkok Post

Bangkok minimarts raided for selling unlicensed drugs

Five employees were arrested and more than 5,000 unlicensed drugs and herbal products seized during a police-led raid on six Bangkok minimarts, some of which employed migrant workers as pharmacists.

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The Independent UK

FDA set to change requirements to get vaccines approved as RFK Jr continues to push skepticism about their use

New FDA framework on changes coronavirus vaccine approval will be released “in the coming days,” FDA Commissioner Marty Makary said Thursday.

The Independent UK

The Latest: Vance calls for greater ties with India as he meets with Modi to discuss trade deal

While in India on Tuesday, U.S. Vice President JD Vance called for enhanced engagement with the South Asian country

The Independent UK

Deadly E. coli outbreak linked to lettuce hit 15 states. The government chose to keep it secret

Questions are now being asked about why the Food and Drug Administration decided to keep the outbreak quiet

The Independent UK

FDA reverses course on telework after layoffs and resignations threaten basic operations

The Food and Drug Administration is reversing course on its requirement for all staffers to report to the office

The Independent UK

FDA staff return to crowded offices, broken equipment and missing chairs

Thousands of Food and Drug Administration employees are returning to the office to find overflowing parking lots, cramped workspaces and missing equipment

The Independent UK

DOGE lease cancellations: Which government offices could be closed this year and when

The General Services Administration, working with Elon Musk’s Department of Government Efficiency, has notified landlords that federal agencies will be terminating hundreds of leases for offices and buildings in the coming months

Roll Call

Senate Democrats press HHS over FDA firings - Roll Call

In letter, senators say recent staff firings could affect drug and device approval, food safety and public health threats.

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