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The US FDA has accepted the resubmitted BLA of UX111 (rebisufligene etisparvovec) for accelerated approval in Sanfilippo syndrome Type A (MPS IIIA), with a PDUFA action date of Sep 19, 2026
UX111 BLA is supported by up to 8yrs. of follow-up data showing durable clinical benefit & acceptable safety. Also, during prior late-cycle review,…
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The P-Ib/II trial randomized 67 MSS CRC pts (65 evaluable) with no liver metastases to muzastotug (10mg/kg; Q3W or Q6W) or muzastotug (20mg/kg) followed by 10mg/kg (Q3W), or 20 mg/kg (Q6W), all in combination with Keytruda; P-II data expected in H1’27
As of Jan 24, 2026, pts in 10mg/kg cohorts (N=39) showed ORR of…
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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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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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FDA has approved extending Eylea HD dosing intervals up to 20wks. for wet age-related macular degeneration (wAMD) & diabetic macular edema (DME) after 1yr. of response based on visual & anatomic outcomes
As a part of approval, the Eylea HD label will incl. 96wk. PULSAR (wAMD; n=583) & PHOTON (DME; n=395) data, where 71%…
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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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Earendil Labs has dosed the first patient with HXN-1001 in the P-IIa trial, & completed enrolment of healthy subjects in the P-I trial across Australia
The P-IIa trial will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of HXN-1001 vs PBO in ulcerative colitis patients
HXN-1001 is a half-life extended anti-TL1A antibody…
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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…
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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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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…

