Azafaros has announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for AZ-3102 to treat GM2 gangliosidosis, including Tay-Sachs disease and Sandhoff disease. GM2 gangliosidosis, a group of rare genetic disorders that...
The U.S. Food and Drug Administration (FDA) has approved Takeda Pharmaceutical’s VONVENDI to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease (VWD). VWD is the most common inherited bleeding disorder that is caused by a...
The U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) for ALX Oncology’s evorpacept, a next-generation CD47 blocker, to treat patients with gastric cancer and gastroesophageal junction cancer. Gastric cancer and gastroesophageal...
The U.S. Food and Drug Administration (FDA) has granted approval of Immunocore’s KIMMTRAK (tebentafusp-tebn) to treat adults who are HLA-A*02:01-positive for unresectable or metastatic uveal melanoma (mUM). Uveal melanoma is a rare and aggressive cancer of the eye, in...
The U.S. Food and Drug Administration (FDA) has cleared Imara’s Investigational New Drug (IND) application for tovinontrine (IMR-687) to treat heart failure with preserved ejection faction (HFpEF). HFpEF (diastolic heart failure) is a form of heart failure that occurs...
Senhwa Biosciences’ Pidnarulex (CX-5461) has been granted a Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of solid tumors with BRCA1/2, PALB2, and other gene mutations. In patients with solid tumors, specifically breast...
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