RARITAN, N.J. – Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations...
treatment News
NEW YORK, NY – Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) an Orphan-Drug Designation (ODD) following submission of results from the randomized controlled trial in children...
Copenhagen, Denmark – Zealand Pharma A/S, a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Part 1 of the New Drug Application (NDA) for dasiglucagon for the prevention...
BIRMINGHAM, Ala. – The University of Alabama at Birmingham startup TIXiMED, Inc., has obtained clearance from the U.S. Food and Drug Administration to proceed to clinical trials under an Investigational New Drug for TIX100, its novel oral Type 1 diabetes drug. This represents a major milestone in the development of...
San Diego, Calif. – UC San Diego Health is the first health system in San Diego County to offer a new bladder-saving gene therapy to treat localized bladder cancer. The novel treatment is the first and only FDA-approved gene therapy delivered directly into the bladder for non-muscle-invasive bladder cancer (NMIBC)....
San Francisco, Calif. – In a discovery that opens the door to a less invasive way of treating some serious disorders before birth, UC San Francisco scientists have found that delivering medicine through amniotic fluid is as effective as delivering it to the fetal brain via cerebrospinal fluid. The experiment...
San Francisco, Calif. – Combining testosterone-blocking drugs in patients with prostate cancer relapse prevents the spread of cancer better than treatment with a single drug, a multi-institution, Phase 3 clinical trial led by UC San Francisco researchers has found. The approach can extend the time between debilitating drug treatments without...
Dapirolizumab pegol (DZP) showed efficacy across multiple clinical endpoints in the PHOENYCS GO study, including fatigue and measures of disease activity DZP showed consistent improvements in fatigue, a common and debilitating symptom of systemic lupus erythematosus (SLE) At Week 48, more individuals receiving DZP experienced no or low disease activity...
ATLANTA, GA — UCB, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for BIMZELX® (bimekizumab-bkzx), an IL-17A and IL-17F inhibitor, for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS). In addition, a second sBLA...
ATLANTA, Georgia — UCB, a global biopharmaceutical company, today presented positive efficacy and safety results from the GEMZ phase 3 study investigating adjunctive fenfluramine (FFA) in children and adults with CDKL5 deficiency disorder (CDD) at the American Epilepsy Society (AES) meeting in Atlanta, December 5-9, 2025.1 The trial met its primary endpoint and...