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.

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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.
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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.

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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

The world’s first Phase 3 psilocybin clinical trial is about to commence

Research into clinical uses for psychedelics has proliferated in recent years, but despite the constant stream of “psychedelic renaissance” news, the vast majority of studies remain in early, preliminary stages. Apart from one notable modality (MDMA-as… Continue reading The world’s first Phase 3 psilocybin clinical trial is about to commence

The world’s first Phase 3 psilocybin clinical trial is about to commence

Research into clinical uses for psychedelics has proliferated in recent years, but despite the constant stream of “psychedelic renaissance” news, the vast majority of studies remain in early, preliminary stages. Apart from one notable modality (MDMA-as… Continue reading The world’s first Phase 3 psilocybin clinical trial is about to commence

The world’s first Phase 3 psilocybin clinical trial is about to commence

Research into clinical uses for psychedelics has proliferated in recent years, but despite the constant stream of “psychedelic renaissance” news, the vast majority of studies remain in early, preliminary stages. Apart from one notable modality (MDMA-as… Continue reading The world’s first Phase 3 psilocybin clinical trial is about to commence

Omicron COVID vaccine booster authorized in US, roll-out begins in days

The US Food and Drug Administration (FDA) has authorized new mRNA vaccine booster shots targeting the BA.4 and BA.5 Omicron variant of SARS-CoV-2. The authorization marks the first updated COVID-19 vaccines to be made available in the United States sin… Continue reading Omicron COVID vaccine booster authorized in US, roll-out begins in days