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The Latest Breaking News from the Food and Drug Administration

FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals

The Independent UK

Moderna says the FDA will consider its new flu shot after resolving a public dispute

Vaccine maker Moderna says the Food and Drug Administration will decide whether to approve its new flu shot for older adults after all

The Independent UK

Frozen salmon sold at wholesaler in seven states recalled over possible listeria contamination

Listeria infection can cause high fever, abdominal pain and diarrhea among otherwise healthy patients

The Independent UK

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What to know about FDA's review of new Zyn advertising proposal

The Food and Drug Administration is weighing whether to allow new advertising messages about Zyn, a type of nicotine pouch that's growing in popularity

The Independent UK

Cheese products from The Ambriola Company, including some under the Boar’s Head brand, were recalled last November

The Independent UK

The FDA’s Understated Concern About Unsecured Healthcare Software

The Food and Drug Administration has long been associated with drug approvals and food safety, but its role in regulating medical technology is just as...

Saving Advice

I treat menopause and its symptoms, and hormone replacement therapy can help – here’s the science behind the FDA’s decision to remove warnings

For more than 20 years, hormone therapy for menopause has carried a warning label from the Food and Drug Administration describing the medication’s risk of serious harms – namely, cancer, cardiovascular disease and possibly dementia.

The Conversation

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FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths

The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year

The Independent UK

FDA removes warning for hormone replacement therapy for menopause - Roll Call

The Food and Drug Administration is removing "black box" warnings on hormone replacement therapy for menopause.

Roll Call

FDA will remove long-standing warning from hormone-based menopause drugs, citing benefits for women

The Food and Drug Administration says it will remove a long-standing warning from hormone-based drugs used to treat menopause symptoms in women

The Independent UK

FDA recall of blood pressure pills due to cancer-causing contaminant may point to higher safety risks in older generic drugs

A generic blood pressure drug called prazosin, made by Teva Pharmaceuticals, is being recalled by the Food and Drug Administration because it contains elevated levels of cancer-causing chemicals called nitrosamines.

The Conversation

FDA Drug Chief George Tidmarsh Resigns After Allegations Of Power Misuse

George Tidmarsh, head of the Food and Drug Administration’s (FDA) drug center, resigned Sunday following allegations that he misused his regulatory power to financially harm a former business associate.

Benzinga

FDA health warning as restriction placed on kids’ fluoride supplements

The agency sent a form letter to dentists and other health providers warning about the risks of the products

The Independent UK

DexCom Faces New Reports Of Deaths Linked To G7 Glucose Monitor

DexCom Inc (NASDAQ:DXCM) is facing renewed scrutiny after three people with diabetes reportedly died following issues with its G7 continuous glucose monitor, according to adverse event filings submitted to the Food and Drug Administration in September.

Benzinga

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Everybody Loves Your Money

7 FDA Approvals That Should Never Have Happened

Every time you see the words “FDA approved,” it’s supposed to mean safety, science, and trust. After all, the Food and Drug Administration is the final checkpoint before a product reaches your medicine cabinet, right? But history says otherwise. Over the years, some truly shocking—and sometimes disastrous—products have slipped through…

Barchart

Tylenol-Maker Kenvue’s Stock Is Down 30% in 2025. Its Fate May Be in the FDA’s Hands.

The former consumer health unit of Johnson & Johnson remains mired in troubles surrounding Tylenol.

The Independent UK

FDA unveils drugs to receive expedited review in support of 'national priorities'

The Food and Drug Administration is announcing the first round of drugs that will receive drastically expedited reviews at the agency

Clever Dude

My Wife Took Tylenol While Pregnant—Should We Worry? Experts Explain

On September 22, 2025, President Donald Trump released a statement suggesting that Tylenol was linked to an increased risk of autism when used by pregnant mothers. He urged pregnant women to stop taking the drug. “Don’t take Tylenol,” Trump said. “Fight like hell not to take it.” On the same…

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Benzinga

What's Going On With Kenvue Stock Tuesday?

Kenvue Inc. (NYSE:KVUE) shares are trading higher Tuesday despite President Donald Trump saying the Food and Drug Administration will notify physicians that use of acetaminophen or Tylenol during pregnancy could be associated with increase risk of autism.

Benzinga

Medtronic's New Implant Could Transform Bladder Control Treatment

Innovative medical technologies are transforming healthcare by tackling chronic conditions that affect millions, offering hope and improved quality of life. The Food and Drug Administration (FDA) approved Medtronic plc’s (NYSE:MDT) Altaviva device on Friday.

The Independent UK

Pharmacies are not offering Covid-19 shots in 16 states as unclear guidance from FDA leaves them in limbo

The Food and Drug Administration recently narrowed who qualifies to receive a Covid-19 vaccine this year

The Conversation

Pregnant women face tough choices about medication use due to lack of safety data − here’s why medical research cuts will make it worse

A panel convened in July 2025 by the Food and Drug Administration sparked controversy by casting doubt about the safety of commonly used antidepressants during pregnancy. But it also raised the broader issue of how little is known about the safety of many medications used in pregnancy, considering the implications…

The Conversation

FDA approves updated COVID-19 vaccines with new restrictions, potentially limiting access for healthy children

Guidance around COVID-19 vaccines has once again shifted after the Food and Drug Administration on Aug. 27, 2025, approved updated shots for the fall season, but for a more limited group than in prior seasons.

The Independent UK

FDA approves updated COVID-19 shots but limits access for some kids and adults

The Food and Drug Administration has approved updated COVID-19 vaccines for the upcoming fall and winter season

Grocery Coupon Guide

10 Everyday Products That Were Labeled “Misleading” by the FDA

Every time you shop, you trust that the products on the shelves are labeled honestly. Yet, even everyday items can carry claims that stretch the truth or mislead shoppers. The Food and Drug Administration (FDA) has flagged many popular products for labeling that could confuse or trick consumers. Understanding which…

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