Category News

FDA

FDA Accepts Genentech’s NDA for Giredestrant in ESR1-Mutated Advanced Breast Cancer

FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer Genentech, a member of the Roche Group announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant,…

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Dock Health

Dock Health Deploys Workflow Productivity Platform at Mayo Clinic

Dock Health Introduces Its Productivity Platform at Mayo Clinic to Modernize Operational Workflows Dock Health today announced that its productivity platformhas been implemented at Mayo Clinic to automate and optimize operational workflows in its cardiovascular, econsult, and specialty contract programs by transforming manual processes into…

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Unified Women’s

Unified Women’s Healthcare Addresses Growing Demand for Menopause Care

Unified Women’s Healthcare Responds to Rising Demand for Menopause Care Unified Women’s Healthcare (Unified), in partnership with its OBGYN affiliates, is expanding access to perimenopause and menopause care nationwide through Unified for You, its patient resource platform and corresponding awareness campaign, which…

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Delcath

WELLTRUST Debuts to Advance AI-Driven Patient Identification in Clinical Research

WELL Health and HEALWELL AI Launch WELLTRUST to Empower Patients and Accelerate AI Powered Ethical Patient Identification for Clinical Research WELL Health Technologies Corp. a technology-enabled healthcare company operating outpatient clinics that leverage scalable digital health solutions, and HEALWELL AI…

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Affinia

Affinia Therapeutics Receives EMA Orphan Designation for Gene Therapy AFTX-201 in BAG3 Cardiomyopathy

Affinia Therapeutics Receives European Medicines Agency Orphan Drug Designation for AFTX-201 in BAG3-Associated Dilated Cardiomyopathy (DCM) Affinia Therapeutics an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases,…

Read MoreAffinia Therapeutics Receives EMA Orphan Designation for Gene Therapy AFTX-201 in BAG3 Cardiomyopathy
Sarepta Therapeutics

Spruce Biosciences Advances TA-ERT Program Following Constructive Type B Discussions with U.S. FDA

Spruce Biosciences Announces Positive Type B Meetings with U.S. FDA for TA-ERT for the Treatment of Sanfilippo Syndrome Type B (MPS IIIB) Spruce Biosciences, Inc. a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant…

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BRAFTOVI

BRAFTOVI Regimen from Pfizer Demonstrates Improved PFS in Advanced Colorectal Cancer

Pfizer’s BRAFTOVI Regimen Improves Progression-Free Survival in Metastatic Colorectal Cancer Pfizer Inc.  today announced positive topline progression-free (PFS) survival results from Cohort 3, a separate randomized cohort of the pivotal BREAKWATER trial, evaluating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as…

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Nuclera

Nuclera, leadXpro Collaborate to Enhance Structure-Guided Drug Discovery for Membrane Protein Targets

Nuclera and leadXpro Partner to Accelerate Structure-Based Drug Design for Complex Membrane Proteins Nuclera, the biotechnology company enabling rapid access to high-quality proteins and leadXpro, a specialist in structure-based drug discovery for membrane proteins, today announced a scientific partnership. The…

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Spine

VB Spine Moves to Secure Exclusive Rights to Augmedics’ Spine Technology Platform

VB Spine Announces Intent to Acquire Exclusive Rights to Augmedics’ Spine Platform VB Spine LLC the largest privately held spine company, today announced it has entered into a definitive agreement to acquire exclusive rights to the xvision Spine System® (xvision) from Augmedics,…

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ECCO Data

ECCO Data Highlight Remsima™ SC’s Ability to Restore and Sustain Disease Control After Treatment Break

New ECCO data show subcutaneous (SC) infliximab (Remsima™  SC) effectively recaptures and maintains disease control after drug holiday Celltrion, Inc. today announced new data from a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), showing that subcutaneous (SC) infliximab…

Read MoreECCO Data Highlight Remsima™ SC’s Ability to Restore and Sustain Disease Control After Treatment Break