fda
A panel of advisers to US health regulators backed a drug to slow Alzheimer's disease on Monday setting the stage for its expected approval for patients at an early stage of the disease. The advisers voted unanimously that the drug's benefits outweighed its risks, which include side effects like brain swelling and bleeding that will have to be monitored. "I thought the evidence was very strong in the trial showing the effectiveness of the drug," said panel member Dean Follmann, a National Institutes of Health statistician. The drug, donanemab, is from pharmaceutical company Eli Lilly and has b...
Euronews (English)
フランス、カストル, 2024年6月6日 /PRNewswire/ -- ピエール・ファーブルは本日...
PR Newswire
A first-of-a-kind proposal to begin using the mind-altering drug MDMA as a treatment for post-traumatic stress disorder (PTSD) in the US was criticised on Tuesday by a panel of experts. In what could be a major setback to advocates hoping to win federal approval for medical psychedelics, a panel of advisers to the Food and Drug Administration (FDA) voted 10-1 against the overall benefits of MDMA when used to treat PTSD. “It seems like there are so many problems with the data - each one alone might be OK, but when you pile them on top of each other … there’s just a lot of questions I would have...
Euronews (English)
Lori Tipton is among the growing number of people who say that MDMA, also known as ecstasy, saved their lives. Raised in New Orleans by a mother with untreated bipolar disorder who later killed herself and two others, Tipton said she endured layers of trauma that eventually forced her to seek treatment for crippling anxiety and hypervigilance. For 10 years nothing helped, and she began to wonder if she was “unfixable.” Then she answered an ad for a clinical trial for MDMA-assisted therapy to treat post-traumatic stress disorder. Tipton said the results were immediate, and she is convinced the ...
Kaiser Health News
Lori Tipton is among the growing number of people who say that MDMA, also known as ecstasy, saved their lives. Raised in New Orleans by a mother with untreated bipolar disorder who later killed herself and two others, Tipton said she endured layers of trauma that eventually forced her to seek treatment for crippling anxiety and hypervigilance. For 10 years nothing helped, and she began to wonder if she was “unfixable.” Then she answered an ad for a clinical trial for MDMA-assisted therapy to treat post-traumatic stress disorder. Tipton said the results were immediate, and she is convinced the ...
California Healthline
The federal government in 2020 and 2023 changed who it said could safely donate organs and blood, reducing the restrictions on men who have had sex with another man. But the FDA’s restrictions on donated tissue, a catchall term encompassing everything from a person’s eyes to their skin and ligaments, remain in place. Advocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular, said they are frustrated the FDA hasn’t heeded their calls. They want to align the guidelines for tissue donated by gay and bisexual men with those that apply to the rest of the human...
Kaiser Health News
The federal government in 2020 and 2023 changed who it said could safely donate organs and blood, reducing the restrictions on men who have had sex with another man. But the FDA’s restrictions on donated tissue, a catchall term encompassing everything from a person’s eyes to their skin and ligaments, remain in place. Advocates, lawmakers, and groups focused on removing barriers to cornea donations, in particular, said they are frustrated the FDA hasn’t heeded their calls. They want to align the guidelines for tissue donated by gay and bisexual men with those that apply to the rest of the human...
California Healthline
The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that has allegedly harmed patients and is now the subject of a criminal investigation. According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later. That inspection found that the Indiana dental device manufacturer didn’t require all cust...
Kaiser Health News
The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or “AGGA,” a dental device that has allegedly harmed patients and is now the subject of a criminal investigation. According to FDA documents obtained through the Freedom of Information Act, the agency “became aware” of the AGGA from a joint investigation by KFF Health News and CBS News in March 2023, then responded with its first-ever inspection of Johns Dental months later. That inspection found that the Indiana dental device manufacturer didn’t require all cust...
California Healthline
When dermatologist Adewole “Ade” Adamson sees people spritzing sunscreen as if it’s cologne at the pool where he lives in Austin, Texas, he wants to intervene. “My wife says I shouldn’t,” he said, “even though most people rarely use enough sunscreen.” At issue is not just whether people are using enough sunscreen, but what ingredients are in it. The Food and Drug Administration’s ability to approve the chemical filters in sunscreens that are sold in countries such as Japan, South Korea, and France is hamstrung by a 1938 U.S. law that requires sunscreens to be tested on animals and classified a...
Kaiser Health News
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