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The Latest Breaking News from FDA

Ex-missionary from Ohio charged with sexually abusing 4 children in Haiti

A former missionary with an Ohio-based ministry has been indicted on federal charges of engaging in illicit sexual conduct with four different minors in Haiti over multiple years

The Independent UK

Pentagon knew boat attack left survivors but still launched a follow-on strike, AP sources say

The Pentagon knew there were survivors after a September attack on an alleged drug boat in the Caribbean Sea and the U.S. military still carried out a follow-up strike

The Independent UK

A dozen former FDA leaders lambast claims by current FDA vaccine chief

A dozen prior leaders of the U.S. Food and Drug Administration issued a scathing denunciation of an FDA memo to staff that made sweeping claims casting doubt on vaccine safety

The Independent UK

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FDA claims on COVID-19 vaccine safety are unsupported by reliable data – and could severely hinder vaccine access

The Food and Drug Administration is seeking to drastically change procedures for testing vaccine safety and approving vaccines, based on unproven claims that mRNA-based COVID-19 vaccines caused the death of at least 10 children.

The Conversation

Analyst Says Viridian's New Thyroid Eye Drug Could Outperform Amgen's Tepezza

William Blair initiated coverage on Viridian Therapeutics Inc. (NASDAQ:VRDN) on Wednesday.

Benzinga

Chatbots Are Not Medical Devices

Why does the FDA want to regulate AI wellness apps?

Reason

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

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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

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

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

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news in one place.

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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.

The Independent 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

International Business Times 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.

The Guardian - US

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

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Benzinga

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.

Saving Advice

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...

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

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.

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