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Denali Regains Full Rights to Frontotemporal Dementia Therapy as Takeda Exits DNL593 Pact

Shots: Takeda has terminated its collaboration with Denali for the co-development & commercialization of DNL593, citing strategic considerations unrelated to safety or efficacy Denali will regain full control of DNL593, a progranulin replacement therapy leveraging its Protein TransportVehicle platform to cross the blood-brain barrier for the treatment of frontotemporal dementia The ongoing P-I/II study has…

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Allevion Secures FDA Clearance for Vantage Spinal Decompression System

Shots: The US FDA has granted 510K Clearance to Vantage, a fully disposable, sterile system designed for minimally invasive lumbar decompression procedures Vantage features a structured “locate, dilate, decompress” workflow with integrated illumination for direct visualization, enabling precise, depth-controlled bone resection while improving procedural consistency & safety  The single-use system eliminates the need for reusable…

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Revolution Medicines Initiates P-III (RASolute 303) Trial of Daraxonrasib in Pancreatic Ductal Adenocarcinoma (PDAC)

Shots: Revolution Medicines has started treatment in global P-III (RASolute 303) trial assessing daraxonrasib (PO) as monotx. & in combination with CT for the treatment of pts with previously untreated metastatic PDAC, irrespective of tumor RAS genotype The trial will assess PFS & OS as 1EP, while the key 2EPs include additional measures of antitumor…

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restor3d Reports Full Commercial Launch of Aeros Modular Stem System for Total Ankle Replacement

Shots: restor3d has reported the full commercial availability of the Aeros Modular Stem System, a next-generation total ankle replacement platform designed to enhance implant stability, preserve bone, & improve surgical efficiency  Launched with a limited market release, the system enables flexible implant configurations and introduces a modular stem tibial implant that can be placed via…

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Zeto Receives US FDA 510(k) Clearance for Zeto New Wave to Advance Outpatient EEG

Shots: The US FDA has granted 510(k) clearance to Zeto New Wave to perform EEG efficiently in outpatient clinics & homes Zeto New Wave is an easy-to-use outpatient EEG system with 21 soft-tip electrodes (10–20 system), offering full head coverage & paired with a compact device capturing synchronized video/audio  Designed for short-term recordings up to 2.5hrs., the…

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