PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today announced positive clinical data and development updates across the RESET-Myositis™, RESET-SSc™ and RESET-SLE trials evaluating rese-cel (resecabtagene autoleucel, formerly...
treatment News
First cleared CD19-CAR T IND application for generalized myasthenia gravis announced in the U.S. and fourth IND clearance for CABA-201 across a broad range of autoimmune diseases Clearance expands the clinical development of CABA-201 beyond rheumatology into neurology Phase 1/2 clinical trial evaluating CABA-201 in generalized myasthenia gravis features...
PARIS, France – Ipsen announced today that the European Commission has approved Cabometyx® (cabozantinib) for adult patients with unresectable or metastatic, well differentiated pancreatic (pNET) and extra-pancreatic (epNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. Most forms of neuroendocrine tumors (NETs) develop slowly,...
OKLAHOMA CITY, Okla. — Cadenza Bio, Inc. today announced that a collaborative study, “Chloroindazole based Estrogen Receptor β ligands with favorable pharmacokinetics promote functional remyelination and visual recovery,” has been published in Scientific Reports (https://www.nature.com/articles/s41598-025-20254-9). The work, authored by scientists from the University of California Riverside, University of Illinois Urbana-Champaign, The...
Research Triangle Park, N.C. — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee (CDEC) has issued a positive recommendation for ORLADEYO® (berotralstat) to be reimbursed for the routine prevention of attacks of hereditary angioedema (HAE) in adults...
BASKING RIDGE, N.J. – Caladrius Biosciences, Inc. (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, today announced that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to the Company’s CD34+ cell therapy product, CLBS12, for...
SAN FRANCISCO, Calif. — Calico Life Sciences LLC (Calico), a biotechnology organization focused on aging and age-related diseases and founded by Alphabet Inc. and Arthur D. Levinson, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABBV-CLS-628, an investigational therapy for the treatment...
SAN DIEGO & LOS ANGELES, Calif. — Calidi Biotherapeutics Inc. (NYSE American: CLDI), a clinical-stage biotechnology company developing a new generation of targeted oncolytic virotherapies, and City of Hope, one of the largest cancer research and treatment organizations in the United States, today jointly announced that the California Institute for...
SAN DIEGO, Calif. — Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today announced that it received Fast Track designation from the U.S. Food and Drug...
NEW TAIPEI CITY, Taiwan — Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to CBL-514 for Dercum’s disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by inducing adipocyte apoptosis, and is the first drug to receive...