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…
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…
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,…
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…
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…
Enveric Biosciences Reports EB-003 BRET Receptor Engagement Assay Data Enveric Biosciences a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today announced new mechanistic data demonstrating that its lead candidate, EB-003, activates both Gq- and…
ECCO 2026 Data Validate Iterative Health’s Site Network Model for Faster, More Consistent Trial Execution Iterative Health, a healthcare technology and services company powering the acceleration of clinical research, today announced the publication of scientific research at the 21st Congress of…
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…
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,…
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…
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…
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…