Eureka Therapeutics: ODD to Treat Hepatocellular Carcinoma
Eureka Therapeutics has announced the US Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) to their therapies, ET140203 and ECT204, for the treatment of hepatocellular carcinoma (HCC). HCC is the most common form of liver cancer and...
NGM Bio’s NGM621 Receives FDA Fast Track Designation
The US Food and Drug Administration (FDA) has granted a Fast Track designation to NGM Bio’s NGM621 for the treatment of patients with geographic atrophy (GA) secondary to age-related macular degeneration. GA is an advanced form of age-related macular degeneration and...
BioCardia: CardiAMP System to Treat Heart Failure
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the BioCardia’s CardiAMP® Cell Therapy System designed for the treatment of heart failure. Heart Failure (HF) is a complex, progressive clinical syndrome that affects the...
Moderna’s COVID-19 Vaccine SPIKEVAX Snatches FDA Approval
The US Food and Drug Administration (FDA) has recently approved Moderna’s mRNA COVID-19 vaccine, SPIKEVAX, becoming the second COVID-19 vaccine to be fully approved in the US. Now marketed under the name SPIKEVAX, the vaccine’s name references the spike-like...
FDA Designation: THE-630 to Treat Gastrointestinal Tumors
Theseus Pharmaceuticals announced the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for THE-630 to treat patients with advanced gastrointestinal stromal tumors (GIST). GIST is the most common sarcoma of the gastrointestinal tract, and...
Azafaros: ODD for AZ-3102 to Treat GM2 Gangliosidosis
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...
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