Author: FDAcop

At the HLTH 2024 conference in Las Vegas, experts discussed the future of psychedelic medicines following the FDA’s decision to delay the approval of MDMA-assisted therapy for PTSD. This setback didn’t mark the end of advancements in the field, as emphasized by various professionals during a panel discussion. Lykos Therapeutics had submitted a new drug […]

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In their recent quarterly earnings updates, orthopedics giants Stryker and Zimmer Biomet showcased distinctly different strategies for fueling their respective growths. Stryker, led by CEO Kevin Lobo, has aggressively pursued acquisitions, highlighting seven recent purchases that span capabilities from virtual hospital workflows with Care.AI, tools for brain surgery and stroke care from Nico Corporation, to […]

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Large language models (LLMs) are on the brink of transforming medical practice, particularly within clinical decision-making processes. This perspective was emphasized by former FDA Commissioner Scott Gottlieb at the 3rd Annual Summit on the Future of Rural Health Care in Sioux Falls, South Dakota. During his presentation, which featured a dialogue with Tommy Ibrahim, the […]

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Crescent Biopharma is poised to enter the public market through a reverse merger with GlycoMimetics, as announced by the companies on Tuesday. Despite being more than a year away from clinical trials, Crescent aims to leverage investor interest sparked by recent advancements in cancer drug development, particularly the impressive performance of Summit Therapeutics’ ivonescimab against […]

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Johnson & Johnson (J&J) recently announced that a key trial for its Impella ECP heart pump has achieved its primary endpoint, bringing the company closer to obtaining approval from the Food and Drug Administration (FDA) for this medical device. The Impella ECP is engineered to be more straightforward in both insertion and implantation compared to […]

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AbbVie, a notable biopharmaceutical company, has made a significant move to enhance its Alzheimer’s disease treatment capabilities through the acquisition of Aliada Therapeutics, a clinical-stage biotech company known for its innovative technology that aids in transporting large molecules, such as antibodies, across the blood-brain barrier (BBB). AbbVie has agreed to pay $1.4 billion in cash […]

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The Food and Drug Administration (FDA) has issued a warning against the use of Hologic’s Biozorb radiographic markers, following multiple reports of serious adverse effects in patients. These implantable devices, which were intended for radiographic marking of soft tissue sites such as breast tissue for future medical procedures, have been recalled but not removed from […]

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During the HLTH 2024 conference in Las Vegas, discussions with health system leaders, venture capital investors, and digital health executives unveiled critical insights into the current trends and emerging challenges in the healthcare sector. Here are seven key takeaways from the conversations that took place over the event’s duration. Artificial Intelligence Exacerbating Health Disparities FDA […]

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In a significant step up for Septerna, a fledgling biotech company, its successful initial public offering (IPO) garnered $288 million. This is a noteworthy achievement considering that Septerna recently entered the clinical stage and lacks human data, making it unique amongst this year’s biotech IPOs. Despite operating in a cautious market environment, the company has […]

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Medtronic has recently achieved a significant milestone with the U.S. Food and Drug Administration’s approval of its Affera mapping and ablation system, intended for the treatment of persistent atrial fibrillation (AFib). This new system, which went into effect following a $925 million acquisition of Affera in 2022, features innovative technology that combines both mapping capabilities […]

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