Month: August 2024

G1 Therapeutics, a biotech firm based in Research Triangle Park, North Carolina, has successfully guided its innovative lung cancer drug, Cosela, to FDA approval. Cosela is uniquely designed not to treat cancer directly but to protect bone marrow by blocking CDK4/6 proteins during chemotherapy for patients with extensive-stage small cell lung cancer. This marks the […]

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Unfortunately, the provided content is too brief and primarily descriptive of what the article aims to cover, rather than presenting substantive information from the article itself. As the text outlines, AgencyIQ analyzes public data to forecast likely actions by the FDA in the near future, which aids regulatory professionals in planning for key FDA-related deadlines, […]

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The Food and Drug Administration (FDA) is seeking public feedback on improving health equity through the regulation of medical devices, as outlined in a new discussion paper. Comments on the paper are open until October 4. This initiative is part of the Center for Devices and Radiological Health’s (CDRH) wider strategy that prioritizes health equity […]

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Jeff Shuren, the longstanding director of the medical device sector at the Food and Drug Administration (FDA), announced his departure in July, leaving many industry leaders, patient advocates, and FDA colleagues taken aback by his unexpected exit. His resignation came as a surprise particularly because Shuren had become a prominent figure within the FDA, admired […]

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Inspire Medical Systems recently received approval from the Food and Drug Administration (FDA) for its new obstructive sleep apnea (OSA) neurostimulator therapy, named Inspire V. The company announced plans to begin a soft launch of the device by the end of 2024 with a full launch projected for 2025. This news came shortly after Inspire […]

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Daniel Wilson has been named the new CFO of iRhythm Technologies, taking over from Brice Bobzien, who will step down due to personal reasons on August 31, as announced by the company. Bobzien, who joined iRhythm in August 2022 from Dexcom, expressed his decision on an earnings call, with CEO Quentin Blackford showing support and […]

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The development of drugs for autoimmune diseases is challenged by immune responses against biologic therapies. Emerging companies employ innovative techniques, including artificial intelligence and novel biologic drug platforms, to mitigate these risks and develop new treatments. Key advancements and investments in the field of Immunology and Inflammation show the dynamic landscape of biotech: Abiologics launched […]

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The content provided is a brief announcement regarding significant organizational and policy changes in U.S. health technology management, specifically within the Department of Health and Human Services (HHS). The news announced includes the creation of a new Assistant Secretary for Technology Policy position within the HHS, showcasing an elevation of responsibilities previously managed by an […]

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Biocompatibility testing is essential for ensuring that medical devices do not cause adverse biological responses when they come into direct or indirect contact with the human body. This type of testing is crucial because it helps to prevent potential harmful effects such as skin irritation, systemic illnesses like cancer, and other serious health issues arising […]

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Kevin Strange has been appointed as the new Chief Financial Officer (CFO) of Inari Medical, slated to begin his new role in early October. This announcement was made by Inari Medical, a company known for its clot removal devices, coinciding with the disclosure of their second-quarter earnings. Strange will be succeeding Mitch Hill, who has […]

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