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The Latest Breaking News from FDA

Bristol Myers Pushes Data Readout For Key Alzheimer's Psychosis Study After Irregularities

Bristol Myers Squibb Co. (NYSE:BMY) on Wednesday said it would enroll additional patients in the ADEPT-2 Phase 3 study.

Benzinga

7 deaths linked to faulty glucose monitors put in people’s arms, FDA says

About three million devices are affected, though many may be expired or already used

The Independent UK

Shredded cheese sold in dozens of states recalled due to potential for metal fragment contamination

The Food and Drug Administration says that there is a recall for more than 260,000 cases of shredded cheese sold in 31 states and Puerto Rico because of potential metal fragment contamination

The Independent UK

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Throw it OUT: Over 1.5 MILLION Bags of Shredded Cheese Pulled After Metal Fragments Found — Are YOU Eating It?

More than 1.5 million bags of shredded cheese have been recalled across the United States after the FDA warned they may contain metal fragments, prompting urgent safety alerts from major retailers.

International Business Times UK

Shredded Cheese Recall Hits Walmart and Target: Metal Fragments Threaten Buyers Across 31 States

A massive shredded cheese recall affects 1.5 million bags sold at Walmart, Target, and Aldi due to feared metal fragments. The FDA classified it as a Class II risk.

International Business Times UK

Pharvaris Pill Provides Rapid Relief In Patients With Rare Swelling Attacks, Data Shows

Pharvaris N.V. (NASDAQ:PHVS) on Wednesday shared topline data from the RAPIDe-3 Phase 3 trial of deucrictibant for the on-demand treatment of hereditary angioedema (HAE) attacks.

Benzinga

FDA drug chief signals possible exit as agency turmoil deepens

Richard Pazdur’s potential retirement weeks into the role adds to upheaval at the FDA amid political pressure

The Guardian - US

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Throw Away Your Old Pots NOW — FDA Issues Chilling Lead Warning Over Dozens of Imported Cooking Pans

The FDA has urgently warned Americans to discard 19 types of imported cookware after tests showed they may leach dangerous levels of lead into food.

International Business Times UK

Cookware Lead Contamination Recall: Which Affected Products Match the Unbranded Cookware Millions Still Use?

FDA widens its cookware lead contamination recall, raising concerns that unlabelled pots used in millions of homes may resemble affected products.

International Business Times UK

New FDA-approved glasses can slow nearsightedness in kids

A new type of lens approved by the FDA promises to slow nearsightedness in children

The Independent UK

FDA Vaccine Chief Claims COVID Shots Linked to 'At Least 10' Child Deaths but Offers No Data

US FDA's vaccine director Dr. Vinay Prasad wrote a memo to their staff that claimed multiple child deaths were related to COVID-19 vaccines without data to back it up.

International Business Times UK

Trump news at a glance: Venezuela suspends all deportation flights after Trump airspace closure warning

Venezuela responds defiantly to Trump comments about closing airspace above country, saying it doesn’t accept foreign orders or threats

The Guardian - US

FDA's Prasad Cites Alleged Child COVID Shot Deaths in Push for Stricter Rules

The Food and Drug Administration’s top vaccine regulator is pushing new limits on how vaccines win approval. The tougher standards could cloud prospects for vaccine makers and rattle investors in major healthcare and biotech names.

Benzinga

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...

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The Guardian - US

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

Axios

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.

The Independent UK

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

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Benzinga

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.

The Guardian - US

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

Benzinga

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.

Benzinga

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.

Benzinga

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.

Benzinga

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.

Benzinga

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.

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