Month: August 2024

The U.S. Food and Drug Administration (FDA) continually monitors the safety of drugs and medical devices even after they have been approved and hit the market. This post-market surveillance is crucial for ensuring the ongoing safety and efficacy of these products. To enhance this surveillance, researchers, including members from the FDA’s Center for Drug Evaluation […]

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The Association for Molecular Pathology (AMP), along with University of Texas pathologist Michael Laposata, has initiated a lawsuit against the Food and Drug Administration (FDA). This legal action is a response to the FDA’s decision to regulate lab-developed tests (LDTs), which the AMP argues exceeds the agency’s regulatory authority. This suit, filed in Texas, marks […]

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Cresilon, a Brooklyn-based startup founded in 2010 by Joe Landolina, a first-year student at New York University, has made significant advances in the field of hemostatic products. Since its inception, the company has raised around $130 million in venture capital and expanded its team to over 80 employees. Recently, Cresilon achieved a major milestone by […]

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Grail, a company specializing in cancer detection tests, recently announced a significant restructuring plan which includes laying off about 350 employees, representing 25% of its workforce as of June 30. This decision follows Grail’s separation from Illumina, its former parent company, which occurred less than two months prior. The layoffs are part of a strategic […]

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Unfortunately, the provided text is too brief and lacks sufficient content to create an 800-word summary. The text is an introduction that refers to an article analyzing the FDA’s finalized guidance on dose optimization for oncology products, which was released a year after the draft guidance. The focus of the article is on understanding the […]

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In a recent development, Tandem Diabetes Care has continued to face challenges with its iPhone app linked to the t:slim X2 insulin pump, as some users still report rapid battery depletion issues despite ongoing software updates aimed at resolving the problem. The difficulties persist even after a recall initiated by the company in March and […]

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Abbott and Medtronic, two renowned leaders in the medical device industry, have historically competed in various healthcare markets. However, in a significant move, they have recently announced a collaboration aiming to enhance diabetes care through advanced technological integration. The partnership focuses on developing a novel continuous glucose monitoring (CGM) system by merging Abbott’s FreeStyle Libre […]

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The summary provided below is based on a fictional article conceived within the prompt given and does not refer to actual events or publications. On August 9, Lykos Therapeutics received a Complete Response Letter (CRL) from the FDA regarding its application for the drug midomafetamine (MDMA) aimed at treating post-traumatic stress disorder (PTSD). This decision […]

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Femtech company Clue, known for its app focused on menstrual cycle tracking and reproductive health, has announced a new partnership with digital mental health provider Headspace. Through this collaboration, members of Clue Plus, Clue’s subscription service, will receive a 50% discount on Headspace subscriptions. This partnership aims to enhance the mental health and mindfulness support […]

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Pfizer and BioNTech are currently developing a combination mRNA vaccine targeting both COVID-19 and influenza, which has shown mixed outcomes in a key clinical trial. The study’s results met only one of the two primary objectives for demonstrating the vaccine’s ability to initiate an immune response, according to an announcement made by the companies on […]

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