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Cytokinetics Reports the EC Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The EC has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with first EU launch expected in Germany by Q2’26 Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by…
February 18, 2026

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CStone Receives the US FDA IND Clearance to Initiate P-II Trial of CS2009 in Advanced Solid Tumors

Shots: The US FDA has granted IND Clearance to initiate P-II trial of CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) in pts with advanced solid tumors CS2009 is being evaluated in a P-II trial (currently enrolling) across Australia & China, spanning 15 cohorts to evaluate monotx. & combination regimens in 9 solid tumors, incl. NSCLC, colorectal cancer, TNBC,…
February 17, 2026

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GSK Reports the EC Approval of Exdensur (Depemokimab) for Asthma with Type 2 Inflammation and CRSwNP

Shots: EC approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively In SWIFT-1 (n=382) & SWIFT-2 (n=380), Exdensur reduced asthma exacerbations by 58% & 48% over 52wks. (1EP), with pooled data showing a 72%…
February 17, 2026

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Bio-Techne’s Ella Platform Receives the CE-IVD Marking for Rapid, Cartridge‑Based Immunoassays

Shots: Bio-Techne has received the European CE-IVD Mark for Ella benchtop immunoassay platform to produce accurate biomarker results in clinical settings Ella is compatible with Simple Plex assays powered by R&D Systems antibodies & proteins, offering over 390 analytes across neuroscience, immunology, oncology, & cell & gene therapy to ensure consistent, high-quality data across diverse research applications…
February 17, 2026

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NEWS

VB Spine to Acquire Exclusive Rights to xvision Spine System from Augmedics

Shots: VB Spine has entered into a definitive agreement with Augmedics to secure exclusive rights to the xvision Spine System, enhancing precision in open, minimally invasive, & percutaneous spine procedures through advanced augmented reality (AR) navigation tech Acquisition will expand VB Spine’s enhanced visualization portfolio by adding AR navigation capabilities, &, subject to regulatory approvals…
February 17, 2026

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Eli lilly
NEWS

Eli Lilly Reports P-III (LIBRETTO-432) Trial Findings on Retevmo (Selpercatinib) in RET Fusion-Positive NSCLC

Shots: Eli Lilly has reported P-III (LIBRETTO-432) trial data assessing Retevmo vs PBO in 151 pts with RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, & other adjuvant therapy, if indicated Trial met its 1EP, showing improvement in investigator-assessed EFS in early-stage (II-IIIA) pts, plus OS data was immature but demonstrated a…
February 17, 2026

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NEWS

LEX Diagnostics Receives 510(k) Clearance and CLIA Waiver Status for its VELO System to Deliver Highly Sensitive PCR Results

Shots: The US FDA has granted 510(k) clearance & CLIA waiver to VELO system for highly sensitive PCR results for respiratory pathogens LEX Diagnostics has completed US trials of the VELO system & Influenza/COVID assay during the 2024/2025 respiratory season, with US commercial activities anticipated in 2026 VELO system allows multiplex PCR testing for respiratory…
February 16, 2026

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Innocare Pharma
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InnoCare Pharma Reports First Patient Dosing in P-II/III Trial of Soficitinib for Chronic Spontaneous Urticaria

Shots: InnoCare has dosed the first patient with soficitinib (ICP-332) in the P-II/III trial for the treatment of chronic spontaneous urticaria Additionally, the company has completed enrolment in soficitinib’s P-III trial for mod. to sev. atopic dermatitis & P-II trial for vitiligo Soficitinib (ICP-332) is a selective TYK2 inhibitor in development for T-cell–mediated autoimmune diseases,…
February 16, 2026

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