Fortress Biotech announced the U.S. FDA has granted Rare Pediatric Disease Designation for CUTX-101 (Copper Histidinate) for the treatment of Menkes disease. Menkes disease is a rare X-linked recessive pediatric disease caused by genetic mutations of the copper...
OBI Pharma announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its antibody-drug conjugate (ADC) targeted cancer therapy, OBI-999, for the treatment of gastric cancer. This is the second Orphan Drug Designation granted to...
GTX-102, being evaluated for the treatment of Angelman syndrome (AS), filed with the U.S. Food and Drug Administration (FDA) is now active. Enrollment in a Phase 1/2 study is expected to begin in the first half of 2020. The phase 1/2 study, named KIK-AS (Knockdown of...
Horizon Therapeutics announced the U.S. FDA has approved Tepezza (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED). Tepezza is the first and only FDA-approved medicine for the treatment of TED. The FDA approval of Tepezza comes ahead of the...
China-based I-Mab (NASDAQ: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development, and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet needs—particularly cancers and autoimmune...
CytoDyn announced today that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA) for the use of leronlimab as an adjuvant therapy for the treatment of metastatic triple-negative breast cancer (mTNBC). The...
