WuXi Biologics Achieves ISO 13485 Certification, Signifying Strong Capabilities in Drug–Device Combination Product Development and Manufacturing WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that it has successfully achieved ISO 13485:2016 Medical Device Quality…
Invivoscribe Announces the PrepQuant™ System, an Integrated Sample Preparation Platform that Standardizes and Streamlines Pre-Analytical Workflows Invivoscribe®, a global leader in precision diagnostics and measurable residual disease (MRD) testing, today announced the launch of the PrepQuant™ System, a novel sample preparation platform that…
Glaukos Receives Permanent J-code for Epioxa™ Glaukos Corporation, an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, announced today the U.S. Centers for Medicare and Medicaid Services (CMS)…
AccurKardia Announces Multi-Year Agreement with Specialized Medical to Power its State-of-the-Art Cardiac Monitoring Operations AccurKardia, an ECG analytics software company focused on establishing ECG as a broad biomarker, today announced a multi-year agreement with Specialized Medical. Under this partnership, AccurKardia’s…
LEO Pharma Announces FDA Acceptance of Supplemental NDA for ANZUPGO® (delgocitinib) Cream for the Treatment of Chronic Hand Eczema in Children Aged 12-17 LEO Pharma Inc., a global leader in medical dermatology, today announced that the U.S. FDA accepted its…
First Patients Dosed with Cabaletta Bio’s Rese-cel Manufactured on Cellares’ Automated Cell Shuttle™ Platform Cellares, the first Integrated Development and Manufacturing Organization (IDMO), today announced that Cabaletta Bio Inc.’s (“Cabaletta Bio” or “Cabaletta”) (Nasdaq: CABA) investigational CAR T cell therapy…
Kashiv BioSciences Strengthens Executive Leadership with New Chief Operating Officer and Senior Vice President of Regulatory Affairs Kashiv BioSciences, LLC (“Kashiv”), a vertically integrated biopharmaceutical company, today announced the appointment of Viet Nguyen as Chief Operating Officer and Arlene Wolny…
Dyve Biosciences and Moffitt Cancer Center Report Promising Study Results for First-of-Its-Kind Topical Therapy Targeting Tumor Acidity Dyve Biosciences, in collaboration with Moffitt Cancer Center, today reported significant study results for a first-of-its-kind investigational therapy applied to the skin and…
Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the First and Only Approved Medicine for FSGS Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has approved FILSPARI® (sparsentan) to reduce proteinuria in adult…
Lineage Announces Formation of Scientific Advisory Board Lineage Cell Therapeutics, Inc., a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf”, cell therapies for serious medical conditions, today announced the formation of a Scientific Advisory Board (SAB) to provide…
AdaptHealth Refinances Credit Facility, Extends Maturity and Lowers Debt Costs AdaptHealth Corp., a national leader in providing patient-centered, healthcare-at-home solutions including home medical equipment, medical supplies, and related services, announced today that it has closed a $1.1 billion senior secured…
Johnson & Johnson Presents New TECNIS PureSee IOL Clinical Data Showing Strong Contrast Sensitivity and Extended Vision Range at ASCRS 2026 Johnson & Johnson (NYSE: JNJ) has announced the presentation of new clinical and real-world data supporting the performance of…