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
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...

CBMG: FDA Designations for Cell Therapy to Treat DLBCL

CBMG: FDA Designations for Cell Therapy to Treat DLBCL

The U.S. Food and Drug Administration (FDA) has granted both a Fast Track Designation and a Regenerative Medicine Advanced Therapy Designation (RMAT) to Cellular Biomedicine’s (CBMG) autologous b-specific therapy, C-CAR039, for the treatment of patients with diffuse...

Advanced NSCLC: EC Approval of Lumykras Treatment

Advanced NSCLC: EC Approval of Lumykras Treatment

The European Commission (EC) has granted a conditional marketing authorization for Amgen’s LUMYKRAS (sotorasib) to treat advanced non-small cell lung cancer (NSCLC) with the KRAS G12C mutation in adults. NSCLC is the leading lung cancer diagnosis globally and includes...

FDA sNDA: REXULTI to Treat Pediatric Schizophrenia

FDA sNDA: REXULTI to Treat Pediatric Schizophrenia

The U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Otsuka and H. Lundbeck’s drug REXULTI for the treatment of schizophrenia in pediatric patients aged 13 to 17. Schizophrenia is a life-long serious disease that is...