October 2025
Trump Administration Pauses Pharmaceutical Tariffs to Negotiate Industry Agreements
Trump; pharmaceutical tariffs; tariff pause; drug pricing; domestic manufacturing; Section 232 investigation; branded drugs; patented drugs
FDA Rejects CUTX-101 for Rare Copper Deficiency Due to Manufacturing Issues
FDA rejection; Menkes disease; CUTX-101; copper deficiency; manufacturing deficiencies; Cyprium Therapeutics; Sentynl Therapeutics; Fortress Biotech
US Government Shutdown Threatens to Stress an Already Depleted FDA
Government shutdown; FDA operations; drug approval delays; FDA staff cuts; user fees; public health; federal funding; regulatory delays
Novartis Receives FDA Approval for Rhapsido: First Oral BTK Inhibitor for Chronic Hives
Novartis; Rhapsido; FDA approval; Bruton’s tyrosine kinase inhibitor (BTKi); remibrutinib; chronic spontaneous urticaria (CSU); chronic hives; immunology; oral therapy; competition
AnaptysBio Announces Strategic Business Split to Create Two Public Companies, Sharpening Asset Focus
AnaptysBio; business split; royalty management; biopharmaceutical development; Jemperli; imsidolimab; public companies; immunology treatments; asset value; restructuring
Star Therapeutics Raises $125M as Bleeding Disorder Therapy Enters Phase III
Star Therapeutics; Series D financing; bleeding disorders; VGA039; Phase III clinical trial; biotech funding; rare diseases; antibody therapy
Novo Nordisk Terminates $598M Heart Failure Cell Therapy Collaboration with Heartseed Amid Major Restructuring
Novo Nordisk; Heartseed; heart failure; cell therapy; HS-001; collaboration termination; strategic restructuring; Maziar Mike Doustdar; diabetes; obesity; biotechnology