IMVARIA Receives 510(k) Clearance for ScreenDx, a First-of-its-Kind Screening Algorithm to Assess for Interstitial Lung Disease

BERKELEY, Calif.–(BUSINESS WIRE)– #510k–IMVARIA Inc., a health tech company pioneering AI-driven digital biomarker solutions, today announced its second FDA authorization, securing 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ScreenDx solution, an AI-powered healthcare tool to assist clinicians in assessing for interstitial lung disease (ILD). “ScreenDx is a software‐only device leveraging artificial intelligence to analyze CT imaging data for findings suggestive of inte
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Datopotamab deruxtecan granted Priority Review in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy. The Food and Drug Administration (FDA) grants Priority Review to
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Advanced Infusion Care (AIC) now offers GC Biopharma’s ALYGLO™ [Immune Globulin Intravenous (Human-stwk) 10% liquid]

DALLAS–(BUSINESS WIRE)–AIC, a division of AIS Healthcare, now offers ALYGLO™, manufactured by GC Biopharma, for the treatment of patients with primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiency (SCID). The nationally accredited home infusion teams at AIC collaborate c
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CareDx Announces Preliminary Fourth Quarter and Full Year 2024 Results

BRISBANE, Calif.–(BUSINESS WIRE)–CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – today reported preliminary, unaudited financial results for the fourth quarter and full year ended December 31, 2024. Preliminary Fourth Quarter 2024 Financial Results Revenue is expected to be between $85 million and $86 million, an increase of approximately 30% year-over-year. Testing services revenue is expected to be between $62.5 million and $63.5 million, an increase of approximately 35% year-over-y
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