The U.S. Food and Drug Administration on Thursday introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare ...
Cintredekin besudotox targets IL-13 alpha-2 receptor in glioblastoma, aiming to spare healthy brain tissue while destroying cancer cells. Orphan drug designation offers benefits like lower fees and ...
AAVB-039 addresses the root cause of the disease, benefitting patients with any ABCA4 mutation AAVB-039 is currently being assessed in the CELESTE interventional clinical trial and we continue ...
Utidelone, a microtubule inhibitor, has received FDA orphan drug designation for pancreatic cancer, offering potential market exclusivity and tax incentives. Clinical trials show utidelone's promising ...
SEATTLE, Oct. 2, 2025 /PRNewswire/ -- Aminex Therapeutics, Inc., a clinical-stage biotechnology company focused on developing novel therapies for rare and difficult-to-treat cancers, today announced ...
Last week, FDA Commissioner Marty Makary, MD, MPH, announced plans to officially lower the standard for how many clinical trials are needed to approve a new drug -- from the long-standing expectation ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback