U.S. FDA Approves TECVAYLI® in Combination with DARZALEX FASPRO® for Relapsed or Refractory Multiple Myeloma Halozyme Therapeutics has announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for the use of TECVAYLI (teclistamab-cqyv)…
European Commission Approves Zynyz® (retifanlimab) as a First-Line Treatment for Patients with Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC) Incyte has announced that the European Commission has granted approval for Zynyz (retifanlimab) to be used in combination with…
NEJM Publishes Phase III ALLEGORY Results Showing Gazyva Reduces Disease Activity in Common Lupus Genentech, a member of the Roche Group, has announced that detailed results from the Phase III ALLEGORY clinical trial evaluating Gazyva (obinutuzumab) in adults with Systemic…
Mirum Pharmaceuticals Provides AZURE Clinical Program Update for brelovitug in Chronic Hepatitis Delta Virus Mirum Pharmaceuticals, Inc. a leading rare disease company, today announced completion of enrollment in the Phase 3 AZURE-1 study and completion of screening in the Phase…
Silence Therapeutics Highlights Recent Business Achievements and Reports Fourth Quarter and Full Year 2025 Financial Results Silence Therapeutics plc, a global clinical-stage company developing novel siRNA (short interfering RNA) therapies, today reported financial results for the fourth quarter and full…
Liberate Bio Secures Myeloid-Optimized CAR Design Licenses to Advance In Vivo CAR-M Programs Liberate Bio, Inc., a biotechnology company developing genetic medicines that deliver RNA therapies directly to immune cells, announces that it has secured exclusive and non-exclusive licenses to…
Xencor Announces Change to Ultomiris® Royalty Revenue Forecast Xencor, Inc. a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, today announced that Alexion Pharmaceuticals, Inc. (the Licensee”) informed Xencor, Inc. (the “Company”) that it…
Vasomune Therapeutics, Inc., and AnGes, Inc., Announce US FDA Clearance of Investigational New Drug (IND) Application For Pegevongitide (AV-001) Treatment in Resuscitation of Severely Burned Patients Vasomune Therapeutics, Inc., a clinical-stage biopharmaceutical company, today announced U.S. Food and Drug Administration…
Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with 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…
Syntis Bio Announces First Patient Dosed in Phase 1/1b Clinical Trial of SYNT-101 in Obesity and Key Leadership Additions Syntis Bio, Inc. a clinical-stage biopharmaceutical company advancing novel oral therapeutics that uniquely leverage the small intestine, today announced that the…
Esperion Therapeutics and Corstasis Therapeutics Announce Esperion’s Definitive Agreement to Acquire Corstasis, Expanding Its Cardiovascular Franchise with Enbumyst™ (bumetanide nasal spray) Esperion and Corstasis Therapeutics Inc., a privately-held, commercial-stage biopharmaceutical company advancing innovative outpatient therapies for the treatment of edema…
The Progeria Research Foundation and Forge Biologics Announce Manufacturing Partnership to Advance Gene Therapy for Children with Progeria The Progeria Research Foundation (“PRF”), a nonprofit research organization dedicated to developing treatments and the cure for Hutchinson-Gilford Progeria Syndrome (“Progeria”), and…