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...
treatment News
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...
NEW TAIPEI CITY, Taiwan — Caliway Biopharmaceuticals announced that the United States Food and Drug Administration (U.S. FDA) has accepted the CBL-514 Investigational New Drug (IND) application of CBL-0202 DD Phase 2 Study to treat Dercum’s Disease. Dercum’s disease is a rare disease characterized by the growth of painful lipomas....
NEW TAIPEI CITY — Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum’s disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by selectively inducing adipocyte apoptosis, and is the first...
CBL-514, Caliway’s novel small molecule drug, was selected for data presentation at the World Orphan Drug Congress USA 2025, highlighting its promising Phase 2 study results (CBL-0201DD) for Dercum’s Disease Treatment. The Phase 2 topline results met all primary and secondary endpoints, with 64.5% of painful lipomas showing ≥ 50% dimension reduction or...