Hoth Therapeutics: Orphan Drug Designation for HT-KIT
Hoth Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to HT-KIT to treat mastocytosis. Mastocytosis is a rare condition caused by an abnormal accumulation and activation of mast cells in the skin, bone...
C4 Therapeutics: Orphan Drug Designation for CFT8634
C4 Therapeutics (C4T) has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to CFT8634 to treat soft tissue sarcoma. Soft tissue sarcoma is a rare type of cancer that begins in the tissues that connect, support, and...
7 Hills Pharma: FDA Fast Track Designation for 7HP349
7 Hills Pharma has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s lead clinical-stage immunostimulant 7HP349, combined with a CTLA-4 inhibitor, to treat unresectable or metastatic malignant melanoma if...
Genmab: Orphan Drug Designation for Epcoritamab
Genmab A/S has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the investigational medicine epcoritamab (DuoBody®-CD3xCD20) to treat follicular lymphoma (FL). FL is usually a slow-growing or indolent form of...
FDA sNDA: Servier’s TIBSOVO® to Treat Acute Myeloid Leukemia
Servier has announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for TIBSOVO® (ivosidenib tablets) in combination with azacitidine to potentially treat patients with previously untreated...
Tonix Pharmaceuticals: Orphan Drug Designation for TNX-2900
Tonix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for TNX-2900 (intranasal potentiated oxytocin) to treat Prader-Willi syndrome. Prader-Willi syndrome is a rare genetic disorder that causes...
ABOUT US
CSOFT Health Sciences has over 15 years of experience providing end-to-end translation and localization solutions for all stages of the product life cycle, from pre-clinical to post-launch. We also specialize in China market access consulting services, Asian regulatory and eCTD submissions. Our operation is compliant with ISO 17100 and certified by BSI in ISO 9001:2015 and ISO 13485:2016, providing customized solutions to meet the rigorous regulatory requirements in global submission. For more information, please visit: www.csoftintl.com