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...
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Rochester, NY – New research has identified the specific biological mechanism behind the muscle dysfunction found in myotonic dystrophy type 1 (DM1) and further shows that calcium channel blockers can reverse these symptoms in animal models of the disease. The researchers believe this class of drugs, widely used to treat...
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...
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...
STOCKHOLM, Sweden — Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) today announced that the FDA has granted an orphan drug exclusivity period of seven years for TARPEYO®, expiring in December 2030 based on when the company obtained full approval with a new indication for this drug product. Following full...
STOCKHOLM, Sweden — Calliditas Therapeutics (Formerly known as Pharmalink), today announced that the U.S. Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. TARPEYO was first approved in...
Beijing, China – Most people with schizophrenia have extensive impairment of memory, including prospective memory, which is the ability to remember to perform future activities. Results from a randomized clinical trial published in Neuropsychopharmacology Reports indicate that repetitive transcranial magnetic stimulation (rTMS), a non-invasive method that uses alternating magnetic fields...
SAN FRANCISCO, California — Including transarterial radioembolization with Yttrium-90 (Y90-TARE) as a neoadjuvant treatment for locally advanced intrahepatic cholangiocarcinoma (CCA) may improve survival outcomes and resection rates compared with chemotherapy alone, according to the results of a recent retrospective analysis presented at the 2024 American Society of Clinical Oncology (ASCO)...