Health Archive

CSOFT’s health sciences blog aims to provide a better understanding of complex diseases, and regulatory polices from conducting experiments to introducing new type of drugs into the market.

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FDA approves Four Cancer Clinical Trials

FDA approves Four Cancer Clinical Trials

Several biopharma companies celebrate the U.S. Food and Drug Administration’s approval for clinical trials involving therapeutics for cancer treatment, including Sonnet BioTherapeutics and Adagene. Sonnet BioTherapeutics evolved into a clinical biopharmaceutical...

Hoth Therapeutics: Orphan Drug Designation for HT-KIT

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: 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: 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: 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...