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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…
April 6, 2026
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…
April 6, 2026
Henlius Receives the NMPA IND Clearance for HLX319 (Biosimilar, Phesgo)
Shots: The Chinese NMPA has granted IND clearance to HLX319, a biosimilar version of Phesgo (pertuzumab, trastuzumab & hyaluronidase), for neoadj./adj. treatment of HER2+ early or locally advanced breast cancer, as well as for the treatment of metastatic breast cancer  Pertuzumab & trastuzumab in HLX319 are Henlius’ HLX11 & Hanquyou, respectively, with HLX11 under review…
April 3, 2026
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…
April 3, 2026
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…
April 3, 2026
Merck new
Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration
Shots: Merck initiates the P-IIb/III (MALBEC) trial assessing MK-8748 (Tiespectus/EYE201) for the treatment of neovascular (wet) age-related macular degeneration (NVAMD) The trial will assess the safety & efficacy of two intravitreal dose levels of MK-8748 vs aflibercept (2mg), with Q4W dosing initially for 3mos., then Q8W through Wk. 48, followed by individualized dosing intervals, with…
April 3, 2026
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