Category News

Savara

Savara Reports FDA Filing of BLA for MOLBREEVI in Autoimmune Pulmonary Alveolar Proteinosis

Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Savara Inc. a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced the FDA has filed for…

Read MoreSavara Reports FDA Filing of BLA for MOLBREEVI in Autoimmune Pulmonary Alveolar Proteinosis
Dr. Reddy’s

Dr. Reddy’s Secures FDA Review of Biologics License Application for Abatacept Biosimilar

Dr. Reddy’s Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable Biosimilar, Abatacept Dr. Reddy’s Laboratories Ltd. along with its subsidiaries together referred to as “Dr. Reddy’s”), today announced that the US Food and Drug Administration…

Read MoreDr. Reddy’s Secures FDA Review of Biologics License Application for Abatacept Biosimilar
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,…

Read MoreFDA Accepts Genentech’s NDA for Giredestrant in ESR1-Mutated Advanced Breast Cancer
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…

Read MoreDock Health Deploys Workflow Productivity Platform at Mayo Clinic
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…

Read MoreUnified Women’s Healthcare Addresses Growing Demand for Menopause Care
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…

Read MoreWELLTRUST Debuts to Advance AI-Driven Patient Identification in Clinical Research
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