FDA Awards QIDP Designation to Evofem Biosciences
The U.S. Food and Drug Administration (FDA) has awarded Evofem Biosciences a Qualified Infectious Disease Product (QIDP) Designation to EVO100 (Phexxi) for the prevention of chlamydia. Chlamydia has been reported to be responsible for up to half of all pelvic...
VCN Biosciences’ VCN-01 Receives FDA Designation
Synthetic Biologics has announced that VCN Biosciences has received an Orphan Drug Designation from the US Food and Drug Administration (FDA) for their therapy, VCN-01, to treat retinoblastoma. Retinoblastoma is a rare cancer of the eye that develops from immature...
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...