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The Latest Breaking News from FDA

The Short-Sellers May Be Right About This Red-Hot Pharma Stock

Palvella Therapeutics (PVLA) is a clinical-stage biopharma stock with no revenue or FDA pipeline. However, the stock has exceptional price momentum with shares up 508% over the past year. PVLA is trading at a new 2-year high and has strong technical indicators. Palvella is highly speculative. It is suitable for...

Barchart

Months Before the ByHeart Recall, Babies Were Already Sick — Parents Ask Why Early Warning Signs Were Missed

ByHeart's voluntary recall of its infant formula this November has raised concerns after families reported babies falling ill months earlier, highlighting potential delays in outbreak detection and regulatory response.

International Business Times UK

Doctors respond to ‘data-free’ decision over menopause hormone therapy: ‘It’s not true’

Physicians say FDA panel conflated two issues and made baseless claims about unproven health benefits

The Guardian - US

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The affected products were sold in 33 states across the U.S.

The Independent UK

Off-label use of COVID-19 vaccines was once discouraged but has become common amid new guidelines

Following the federal government’s changes to COVID-19 vaccine eligibility and recommendations in 2025, many people are wondering whether they can get COVID-19 vaccines for themselves or their children.

The Conversation

Several states have banned kratom, an unregulated supplement, that has been linked to six deaths in Los Angeles County

The Independent UK

Number of infants hospitalized with botulism climbs to 31 as outbreak linked to recalled formula continues

The outbreak has affected 15 states with Texas seeing the most cases

The Independent UK

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Popular ice cream bars urgently recalled over health risk

Recalled ice cream bars were sold to grocery stores nationwide

The Independent UK

Short Seller Alleges Praxis Precision's Potential $3 Billion Drug 'A House Of Cards'

A short seller is challenging Praxis Precision Medicines Inc. (NASDAQ:PRAX) after the company claimed success from its Phase 3 trial of ulixacaltamide.

Benzinga

RFK Jr updates CDC website to link vaccines to autism despite years of agency fighting misinformation

The website now states that “studies supporting a link have been ignored by health authorities.”

The Independent UK

This Leading Gene-Editing Stock Could Be Going Private. Should You Buy Its Shares First?

CRISPR Therapeutics is the subject of strong buyout speculation after earning FDA approval for a breakthrough gene-editing therapy.

Barchart

Why GRAIL Stock Could Be Biotech’s Next Big Breakout

Explore insider buying signals, a promising cancer detection biotech, and why the American Dream is still achievable—even in a down market.

MarketBeat

Gene Editing Medicine and Personalized Medicine: Breakthroughs Driving Health Innovation Gene Therapy to Transform Care

Explore how gene editing medicine and personalized medicine future breakthroughs are revolutionizing health innovation gene therapy, offering precise, transformative treatments and medical breakthroughs for complex diseases.

Medical Daily

Cheese recalled over potential serious health risk

The recalled cheese was sold in Oregon

The Independent UK

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The Conversation

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.

Kids Ain't Cheap

10 Common Baby Products Now Under FDA Scrutiny

Image source: shutterstock.com

International Business Times UK

With $199 Price, Ozempic Prescriptions Expected to Soar — Experts Warn of Risks

Novo Nordisk's new $199 offer for Ozempic and Wegovy aims to improve access for obesity and diabetes treatments, but experts warn of potential serious side effects.

The Independent UK

Dietary supplements recalled nationwide after 11 people sickened with salmonella

Three people have been hospitalized amid the latest salmonella outbreak

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International Business Times UK

From 15 to 23 Cases: ByHeart Infant Formula Outbreak Shows How Quickly Safety Signals Escalate

The ByHeart infant formula botulism outbreak has grown to 23 cases across 13 states, raising urgent questions about food safety oversight and federal preparedness.

Grocery Coupon Guide

You grab your favorite cheeseburger from a drive-thru window. That melty, gooey slice on top looks perfect. But here’s the thing: it might not be real cheese. Yeah, you read that right.

The Guardian - US

Turmoil and tensions at FDA after dramatic exit of top drug regulator

Scramble to find replacement for George Tidmarsh shines light on dysfunction at US regulatory agency

Axios

This new eye drop could help adults with age-related vision issues

The drops specifically combat presbyopia, an age related blurry vision issue.

The Independent UK

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

MarketBeat

Eli Lilly Strikes Deal With Trump: Why Shares Are Up 10% Since

Eli Lilly's blockbuster drug Zepbound could be getting a big new customer: Medicare. See the implications of the company's recent deal with President Trump.

Benzinga

Merck Makes Big Bet On Flu Protection With Cidara Buyout

Merck Co. Inc. (NYSE:MRK) on Friday agreed to acquire Cidara Therapeutics, Inc. (NASDAQ:CDTX) for $221.50 per share in cash, for a total transaction value of approximately $9.2 billion.

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