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The Latest Breaking News from FDA

Stem Cell Therapy Uses: What Regenerative Medicine Can Treat—and the Stem Cell Risks to Know

Stem cell therapy uses are expanding in regenerative medicine, but risks and limits remain. Learn which conditions stem cells can treat safely and which remain experimental.

Medical Daily

Why Requirements Management Is Critical in Regulated Device Development

In the development of regulated medical devices, adherence to stringent regulatory requirements is not optional but a foundational necessity. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others around the world enforce strict guidelines to ensure the safety, efficacy, and reliability…

inkl

Families of people killed in UPS cargo plane crash sue carrier for wrongful death

The crash in Kentucky of an MD-11 cargo plane killed 14 people and injured 23 others on November 4

The Independent UK

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Praxis' Epilepsy Drug Too Good To Continue, FDA Meeting Up Next

Praxis Precision Medicines Inc. (NASDAQ:PRAX) stock rose Friday after the company shared results from the registrational cohort of the EMBOLD study evaluating relutrigine for the treatment of patients with SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs).

Benzinga

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

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

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The Guardian - US

‘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

Axios

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.

The Independent UK

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

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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.

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

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