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Management: Food and Drug Administration (FDA)

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Total 5166 results found since Jan 2013.

Egypt: Coronavirus Oral Administration Drug Expected in Egypt This Month
[Egypt Online] Spokesman for the Ministry of Health and Population Hossam Abdel Ghaffar said Monday international health organizations such as the US Food and Drug Administration and the European Medicine Agency approved new kinds of COVID-19 medicine including an oral administration drug where the substance is taken by mouth.
Source: AllAfrica News: Health and Medicine - January 4, 2022 Category: African Health Source Type: news

Heart Experts Cast Doubt on Claims That Russian Skater ’s Drug Test Was Contaminated by Her Grandfather’s Medicine
The latest revelations about Russian figure skater Kamila Valieva’s doping case raise more questions about the substances found in her sample—and the reasons why the 15-year-old might have failed the drug test. TIME asked leading experts to help make sense of the claims, which have upended the women’s figure skating competition at the Beijing Olympics and cast a larger pall over the sport. At the hearing held on Sunday by the Court of Arbitration for Sport (CAS), anti-doping authorities revealed that Valieva tested positive for three heart treatment drugs, one of which is banned as a performance-enhancer ...
Source: TIME: Health - February 16, 2022 Category: Consumer Health News Authors: Alice Park Tags: Uncategorized 2022 olympics overnight Second click Source Type: news

Man Who Got First Pig Heart Transplant Dies After Two Months
The first person to receive a heart transplant from a pig has died, two months after the groundbreaking experiment, the Maryland hospital that performed the surgery announced Wednesday. David Bennett, 57, died Tuesday at the University of Maryland Medical Center. Doctors didn’t give an exact cause of death, saying only that his condition had begun deteriorating several days earlier. Bennett’s son praised the hospital for offering the last-ditch experiment, saying the family hoped it would help further efforts to end the organ shortage. “We are grateful for every innovative moment, every crazy dream, every...
Source: TIME: Health - March 9, 2022 Category: Consumer Health News Authors: LAURAN NEERGAARD and CARLA K. JOHNSON / AP Tags: Uncategorized healthscienceclimate medicine News Desk wire Source Type: news

Current Status of PSMA-Targeted Radioligand Therapy in the Era of Radiopharmaceutical Therapy Acquiring Marketing Authorization
AbstractProstate-specific membrane antigen (PSMA) is highly expressed in PCa, which gradually increases in high-grade tumors, metastatic tumors, and tumors nonresponsive to androgen deprivation therapy. PSMA has been a topic of interest during the past decade for both diagnostic and therapeutic targets. Radioligand therapy (RLT) utilizes the delivery of radioactive nuclides to tumors and tumor-associated targets, and it has shown better efficacy with minimal toxicity compared to other systemic cancer therapies. Nuclear medicine has faced a new turning point claiming theranosis as the core of academic identity, since new RL...
Source: Nuclear Medicine and Molecular Imaging - August 20, 2022 Category: Nuclear Medicine Source Type: research

Trial of a prehospital intervention with traditional Chinese medicine for acute stroke (TRACE): Protocol for a mixed-methods research study
Discussion: The results of the TRACE study will provide preliminary evidence for the relationship between XNJI used within 24 h of onset and the presence of END on the third day after stroke onset; it will aid in improving the current knowledge regarding the early use of XNJI for stroke first aid.Clinical Trial Registration:clinicaltrials.gov, identifier NCT04275349
Source: Frontiers in Pharmacology - August 29, 2022 Category: Drugs & Pharmacology Source Type: research

How AI Is Changing Medical Imaging to Improve Patient Care
That doctors can peer into the human body without making a single incision once seemed like a miraculous concept. But medical imaging in radiology has come a long way, and the latest artificial intelligence (AI)-driven techniques are going much further: exploiting the massive computing abilities of AI and machine learning to mine body scans for differences that even the human eye can miss. Imaging in medicine now involves sophisticated ways of analyzing every data point to distinguish disease from health and signal from noise. If the first few decades of radiology were about refining the resolution of the pictures taken of...
Source: TIME: Health - November 4, 2022 Category: Consumer Health News Authors: Alice Park and Video by Andrew D. Johnson Tags: Uncategorized Frontiers of Medicine 2022 healthscienceclimate Innovation sponsorshipblock Source Type: news

Current Status of PSMA-Targeted Radioligand Therapy in the Era of Radiopharmaceutical Therapy Acquiring Marketing Authorization
Nucl Med Mol Imaging. 2022 Dec;56(6):263-281. doi: 10.1007/s13139-022-00764-4. Epub 2022 Aug 20.ABSTRACTProstate-specific membrane antigen (PSMA) is highly expressed in PCa, which gradually increases in high-grade tumors, metastatic tumors, and tumors nonresponsive to androgen deprivation therapy. PSMA has been a topic of interest during the past decade for both diagnostic and therapeutic targets. Radioligand therapy (RLT) utilizes the delivery of radioactive nuclides to tumors and tumor-associated targets, and it has shown better efficacy with minimal toxicity compared to other systemic cancer therapies. Nuclear medicine ...
Source: Molecular Medicine - November 25, 2022 Category: Molecular Biology Authors: So Won Oh Minseok Suh Gi Jeong Cheon Source Type: research

FDA Approves Second Monoclonal Antibody Medication for Alzheimer ’s
The Food and Drug Administration (FDA) on Fridayapproved lecanemab for the treatment of Alzheimer ’s disease. Lecanemab (brand name Leqembi) is the second monoclonal antibody approved for Alzheimer’s that targets a biological component of the disease rather than Alzheimer’s-associated symptoms, such as agitation. The approval of the other monoclonal antibody called aducanumab (Aduhelm) in 2021 was met withsome controversy. Both medications attach to amyloid proteins in the brain and prevent the formation of amyloid plaques, which are associated with Alzheimer ’s.Lecanemab was approved under the FDA ’s accelerated...
Source: Psychiatr News - January 9, 2023 Category: Psychiatry Tags: Alzheimer ' s disease amyloid plaques drug development FDA lacanemab Leqembi monoclonal antibody New England Journal of Medicine Source Type: research

When true enough is not good enough
Nature Medicine 19, 1 (2013). doi:10.1038/nm.3061 A recent court ruling that favored freedom of speech over the authority of the US Food and Drug Administration (FDA) to regulate off-label drug promotion may have profound implications for the way drugs are marketed and, ultimately, for patients' interests.
Source: Nature Medicine - January 7, 2013 Category: Journals (General) Tags: Editorial Source Type: research

This Week in Medicine January 12–18, 2013
The US Food and Drug Administration has approved the use of bedaquiline as part of combination treatments for multidrug-resistant tuberculosis (MDR-TB) when there are no other options available. Despite some associated risks, bedaquiline fills an unmet need against this serious disease and was found efficacious in phase 2 clinical trials.
Source: LANCET - January 11, 2013 Category: Journals (General) Authors: The Lancet Tags: This Week in Medicine Source Type: research

A call to prevent unsafe high-risk medical devices from reaching the marketplace
(University of California - San Francisco) Technological advancements in medicine have allowed patients suffering from musculoskeletal conditions such as hip and knee pain to regain mobility and live relatively pain-free. But some "high risk" surgical devices that have been approved by the US Food and Drug Administration are not required to go through clinical trials, where a product is tested to determine its safety and effectiveness.
Source: EurekAlert! - Medicine and Health - January 22, 2013 Category: Global & Universal Source Type: news

This Week in Medicine January 26–February 1, 2013
The US Food and Drug Administration has approved the first seasonal influenza vaccine to be manufactured using recombinant DNA technology. The trivalent Flublok vaccine can be produced more quickly than can other influenza vaccines, which are made by incubating the virus in chicken eggs, and can be given to patients who have egg allergies.
Source: LANCET - January 26, 2013 Category: Journals (General) Authors: The Lancet Tags: This Week in Medicine Source Type: research

Institute of Medicine Seeks to Combat Conterfeit Drug Problem
Fighting the problem of fake drugs will require putting medications through a chain of custody like U.S. courts require for evidence in a trial, the Institute of Medicine reported Wednesday.The call for a national drug tracking system comes a week after the Food and Drug Administration warned doctors, for the third time in about a year, that it discovered a counterfeit batch of the cancer drug Avastin that lacked the real tumor-killing ingredient.
Source: PharmaManufacturing.com - February 13, 2013 Category: Pharmaceuticals Authors: Pharma Manufacturing Source Type: news

FDA Commissioner Margaret A. Hamburg's Statement on the Institute of Medicine's Report 'Countering the Problem of Falsified and Substandard Drugs'
The U.S. Food and Drug Administration commends the Institute of Medicine (IOM) for its thorough discussion and recommendations outlined in its report, “Countering the Problem of Falsified and Substandard Drugs12.” The report...
Source: Drugs.com - Pharma News - February 14, 2013 Category: Pharmaceuticals Source Type: news