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The Latest Breaking News from FDA

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...

Experts say strict new FDA protocol for vaccine approval is ‘dangerous and irresponsible’

Experts say strict new FDA protocol for vaccine approval is ‘dangerous and irresponsible’

Lead FDA vaccine regulator announced new approval process after claiming Covid vaccine had killed 10 children

The Guardian - US

Top FDA official threatens to crack down on vaccine approvals

Top FDA official threatens to crack down on vaccine approvals

The internal memo comes after an internal agency review linked COVID-19 vaccines to the deaths of 10 children.

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FDA to introduce new Covid-19 vaccine protocol after report claims shots killed 10 children

The FDA will also review its guidance for annual flu shots, according to a memo

The Independent UK

Wegmans cheese recalled across the east coast over listeria fears

Recall is the latest affecting cheese products

The Independent UK

Ascendis Pharma Hit By FDA Delay As TransCon CNP Decision Slips To 2026

The U.S. Food Drug Administration (FDA) on Tuesday extended review for Ascendis Pharma A/S‘ (NASDAQ:ASND) New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia.

FDA poised to kill proposal that would require asbestos testing for cosmetics

RFK Jr signed order withdrawing rule that would mandate testing for the cancer-linked toxin in talc-based makeup

The Guardian - US

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Anthony Fauci Under Fresh Fire As FDA Chief Makary Argues COVID-19 Lab Leak Theory Was 'Massive Cover-Up:' 'It's A No Brainer...'

Anthony Fauci Under Fresh Fire As FDA Chief Makary Argues COVID-19 Lab Leak Theory Was 'Massive Cover-Up:' 'It's A No Brainer...'

The U.S. Food and Drug Administration’s (FDA) top official ignited fresh debate on Wednesday by accusing Dr Anthony Fauci on the “Pod Force One” podcast of suppressing early scrutiny of COVID-19’s origins, calling the alleged effort a “massive cover-up” during the first months of the pandemic.

Novo Nordisk Wants FDA Nod For A Higher-Dose Wegovy

On Wednesday, Novo Nordisk A/S (NYSE:NVO) submitted its supplemental marketing application to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg for chronic weight management.

BiomX Awaits FDA Clearance To Restart Cystic Fibrosis Trial After Nebulizer Device Review

BiomX Awaits FDA Clearance To Restart Cystic Fibrosis Trial After Nebulizer Device Review

BiomX Inc. (NYSE:PHGE) on Tuesday announced that the U.S. Food and Drug Administration (FDA) is continuing its evaluation of the nebulizer device used for drug administration in the company's Phase 2b trial of BX004 in cystic fibrosis patients.

What's Going On With Johnson & Johnson Stock On Wednesday?

What's Going On With Johnson & Johnson Stock On Wednesday?

Johnson Johnson (NYSE:JNJ) stock has surged almost 42.9% in the year to date, approximately 35% in 6 months, and 8.6% in one month.

AstraZeneca Wins FDA Nod For Imfinzi Combination Regimen In Tough-To-Treat Stomach Cancers

AstraZeneca Wins FDA Nod For Imfinzi Combination Regimen In Tough-To-Treat Stomach Cancers

The U.S. Food and Drug Administration (FDA) on Tuesday approved AstraZeneca Plc's (NASDAQ:AZN) Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) for resectable, early-stage, and locally advanced gastric and gastroesophageal junction (GEJ) cancers.

ByHeart Infant Formula Recall Expands After Botulism Bacteria Found in Labs

ByHeart Infant Formula Recall Expands After Botulism Bacteria Found in Labs

ByHeart expands its infant formula recall after tests detect botulism-causing bacteria linked to illnesses in dozens of babies.

International Business Times

12 Everyday Items That Became Illegal Overnight

12 Everyday Items That Became Illegal Overnight

We often take our mundane grocery store runs for granted. Generally, we assume that everything sitting on a retail shelf is safe, tested, and entirely legal to own. However, laws change much more rapidly than we realize. What was a household staple yesterday can easily become contraband today.

Budget and the Bees

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Sarepta Secures FDA Nod For Elevidys Study To Reduce Liver Injury Risk

The U.S. Food and Drug Administration (FDA) on Tuesday approved dosing in Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) Cohort 8 of ENDEAVOR (Study 9001-103).

'Catch Kits' for Fetal Remains Are Republicans' Latest Dystopian Plan To Punish Abortions

GOP lawmakers in Wisconsin and elsewhere are pushing the idea that abortions are a water quality issue.

The Surprising Way to Reduce Your Dementia Risk

Lower your dementia risk with this one hack.

Can Your Pacemaker Be Hacked? The Hidden Threat in Connected Medical Devices

Imagine carrying a device inside your chest that keeps you alive, yet could be accessed by hackers. Pacemakers and other connected medical devices are designed...

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Why Is Biogen Stock Trading Higher After Semaglutide Alzheimer's Data?

Biogen Inc. (NASDAQ:BIIB) stock traded higher after Novo Nordisk A/S (NYSE:NVO) released disappointing topline results from the 2-year primary analysis of Evoke and Evoke+ phase 3 trials in early-stage symptomatic Alzheimer's disease.

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...

International Business Times UK

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.

The Guardian - US

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 Independent UK

Popular dessert bun recalled over potential health risk

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

The Conversation

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 Independent UK

A popular supplement has been linked to the deaths of six people in California. But no one knows the exact danger it poses

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

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