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 (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 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 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...
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 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...
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