Select Page

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.

Home 9 Health 9 Archive
Axcella: FDA Fast Track for AXA1125 to Treat NASH

Axcella: FDA Fast Track for AXA1125 to Treat NASH

The US Food and Drug Administration (FDA) has granted a Fast Track Designation to Axcella Therapeutics’ AXA1125 to treat non-alcoholic steatohepatitis (NASH) with liver fibrosis. NASH is the most severe form of fatty liver disease and if left untreated, can lead to...

FDA Awards QIDP Designation to Evofem Biosciences

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

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...

NGM Bio’s NGM621 Receives FDA Fast Track Designation

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

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...

Azafaros: ODD for AZ-3102 to Treat GM2 Gangliosidosis

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...

FDA Approval: Prophylactic Treatment for Type 3 VWD

FDA Approval: Prophylactic Treatment for Type 3 VWD

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...

ALX Oncology: Evorpacept Receives ODD to Treat GC

ALX Oncology: Evorpacept Receives ODD to Treat GC

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...

Pidnarulex: FDA Fast Track to Treat Solid Tumors

Pidnarulex: FDA Fast Track to Treat Solid Tumors

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...

VYVGART: Approval for Treatment of Myasthenia Gravis

VYVGART: Approval for Treatment of Myasthenia Gravis

Japan’s Ministry of Health, Labour, and Welfare (MHLW) has approved agrenx SE’s VYVGART (efgartigimod alfa) intravenous infusion for the treatment of generalized myasthenia gravis (gMG) in adult patients who did not see improvements from pervious treatment with...