International alert as fake Ozempic leads to serious hospitalizations

With an industry expected to be worth US$100 billion by 2030, an ongoing supply crisis, a time-consuming manufacturing process, a high price tag and no generic alternatives, it’s no surprise the much-hyped class of injectable weight-loss drugs has beco… Continue reading International alert as fake Ozempic leads to serious hospitalizations

FDA cyber mandates for medical devices goes into effect

The Biden administration is pushing the manufacturers of medical devices to take on greater responsibility to ensure that they are secure.

The post FDA cyber mandates for medical devices goes into effect appeared first on CyberScoop.

Continue reading FDA cyber mandates for medical devices goes into effect

Over-the-counter cold medications don’t work, FDA panel rules

Adding weight to the large body of scientific evidence showing that phenylephrine is as useless as a placebo for nasal congestion, a US Food and Drug Administration (FDA) advisory panel has unanimously declared common oral medications ineffective. It p… Continue reading Over-the-counter cold medications don’t work, FDA panel rules

Despite alarm, sweetener still deemed safer than bacon and red meat

As forecast in June, the cancer-research arm of the World Health Organization (WHO) has officially named the non-sugar sweetener aspartame as possibly carcinogenic to humans.Continue ReadingCategory: ScienceTags: World Health Organization, FDA, Cancer,… Continue reading Despite alarm, sweetener still deemed safer than bacon and red meat

FDA approves very first drug shown to slow Alzheimer’s disease

While not a cure, Leqembi may offer suitable patients more time with loved ones and an extended quality of life

The first Alzheimer’s disease medication shown in trials to slow progression of the disease has been given full approval by the Food and Drug Administration (FDA), paving the way for its costly price tag to be covered by Medicare.

Continue Reading

Category: Medical, Science

Tags: , , , ,

Continue reading FDA approves very first drug shown to slow Alzheimer’s disease

FDA Announces New Cybersecurity Requirements for Medical Devices

The FDA is asking medical device manufacturers to provide cybersecurity-related information when submitting an application for a new product.
The post FDA Announces New Cybersecurity Requirements for Medical Devices appeared first on SecurityWeek.
Continue reading FDA Announces New Cybersecurity Requirements for Medical Devices

Another controversial FDA approval for a new Alzheimer’s medication

The approval of a drug for Alzheimer's follows several recently reported deaths of clinical trial participants

The U.S. Food and Drug Administration (FDA) has approved a new drug for patients in the early-stages of Alzheimer’s disease. Called Leqembi (lecanemab) the treatment was heralded last year as a major breakthrough in Alzheimer’s therapy following early Phase 3 data indicating it could slow the progression of cognitive decline. But growing concerns over the drug’s safety and real-world efficacy have led to acrimonious division amongst researchers, with some suggesting the drug should not be authorized for wide use.

Continue Reading

Category: Medical, Science

Tags: , , , ,

Continue reading Another controversial FDA approval for a new Alzheimer’s medication

First drug that delays onset of type 1 diabetes approved by FDA

The US Food and Drug Administration (FDA) has approved the first drug that can delay the onset of type 1 diabetes. A recent trial has shown that the drug, named teplizumab, can give patients several extra disease-free years.Continue ReadingCategory: Me… Continue reading First drug that delays onset of type 1 diabetes approved by FDA

FDA gives green light to first lab-grown chicken product in US

California company Upside Foods has been given the green light from the U.S. Food and Drug Administration (FDA) for its lab-grown chicken, paving the way for its product to reach market shelves next year, and making the US the second country in the wor… Continue reading FDA gives green light to first lab-grown chicken product in US