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The Latest Breaking News from FDA

Denali Flags Minimal Delay After FDA Halts Rare Disease Trial Start

The U.S. Food and Drug Administration (FDA) placed a clinical hold on Denali Therapeutics Inc.’s (NASDAQ:DNLI) investigational new drug (IND) application for the Phase 1 study of DNL952 under development for Pompe disease.

Benzinga

FDA Warns Against Abbott Glucose Monitor Sensors After Reports Of Over 700 Injuries, 7 Deaths

The U.S. Food and Drug Administration (FDA) in December issued a safety alert urging people with diabetes to stop using select glucose sensors made by Abbott Laboratories’ (NYSE:ABT) Diabetes Care, after the company linked the devices to seven deaths and hundreds of serious injuries.

Benzinga

Faulty glucose monitors linked to 7 deaths and more than 700 injuries worldwide. Here’s what we know

The sensors provide real-time measurements of sugar levels in the blood, sending that data wirelessly to a device or phone.

Euronews

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Best 7 Pharmaceutical Filtration Solution Providers in 2025

Efficient filtration is the backbone of pharmaceutical manufacturing in 2025.

inkl

Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns

The U.S. Food and Drug Administration warned people to stop using certain types of glucose monitor sensors that were linked to seven deaths

The Independent UK

Baby formula that sickened 39 babies with botulism is still on some store shelves, the FDA warns

Nearly two dozen states have seen cases of infant botulism in an outbreak that has taken an emotional toll on parents across the country

The Independent UK

Axogen Smashes 52-Week High On FDA Nod For Breakthrough Nerve Repair Treatment

The U.S. Food and Drug Administration (FDA) on Wednesday approved Axogen Inc.’s (NASDAQ:AXGN) Biologics License Application for Avance, an acellular nerve scaffold for adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities.

Benzinga

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A 74 year-old woman distributed 150,000 doses of fentanyl in the mail in ‘side hustle’ to pay for her meds

The elderly woman sent more than 1,000 parcels suspected to have contained illegal drugs, with a raid on her Austin home uncovering 18,000 pills

The Independent UK

Thermo Fisher Teams Up With UK Firm To Scale Genetic Heart Disease Screening

UK-based GENinCode PLC unveiled a wide-ranging commercial partnership with Thermo Fisher Scientific Inc (NYSE:TMO) to manufacture, sell, and distribute its CARDIO inCode-Score test.

Benzinga

Medtronic Scores FDA Win As Hugo Surgical Robot Enters 230,000 Urology Procedure Market

On Wednesday, the U.S. Food and Drug Administration (FDA) cleared Medtronic Plc’s (NYSE:MDT) Hugo robotic-assisted surgery (RAS) system for use in urologic surgical procedures.

Benzinga

‘Never seen anything like this’: alarm at memo from top US vaccine official

Vinay Prasad memo said at least 10 children had died from Covid vaccination – but offered scant evidence for claim

The Guardian - US

FDA reaches "tipping point" after high-level departures

Biotech and pharmaceutical companies rely on the FDA for guidance as they spend huge sums developing treatments.

Axios

Huge recall of shredded cheese sold at Aldi, Target, Walmart amid metal fragment concerns

Check the list of affected products here.

Axios

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

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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 Conversation

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.

Benzinga

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.

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Reason

Chatbots Are Not Medical Devices

Why does the FDA want to regulate AI wellness apps?

Benzinga

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.

The Independent UK

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

International Business Times 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.

Benzinga

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.

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