Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
“This designation, following the Orphan Drug designation granted last month, reinforces the promise of amezalpat as a potential treatment option for patients affected by HCC. We look forward to ...
Orphan Drug and Rare Pediatric Disease designations follow U.S. FDA acceptance of IND application for ABO-101 for the treatment of PH1, with Phase 1/2 trial initiation anticipated in H1 2025.
In 2012, Depomed, Inc., filed suit against the U.S. Department of Health and Human Services (of which the FDA is an agency) seeking orphan drug designation for Gralise, which treats after-shingles ...
has granted Orphan Drug Designation (ODD) to its proprietary radiopharmaceutical, 225Ac-satoreotide, for treating patients with Small Cell Lung Cancer (SCLC). SCLC is a severe condition with a poor ...