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
I-Mab’s TJ-CD4B Receives FDA Orphan Drug Designation

I-Mab’s TJ-CD4B Receives FDA Orphan Drug Designation

I-Mab has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its novel Claudin 18.2 x 4-1BB bispecific antibody, TJ-CD4B, to treat gastric cancer, including cancer of gastroesophageal junction. TJ-CD4B is the first...

FDA Approval: eCoin® to Treat Urinary Urge Incontinence

FDA Approval: eCoin® to Treat Urinary Urge Incontinence

Valencia Technologies announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin® tibial neurostimulator to treat urinary urge incontinence (UUI). UUI, affecting over 60% of patients who suffer from Overactive Bladder...

Legend Biotech: CARVYKTI™ to Treat Multiple Myeloma

Legend Biotech: CARVYKTI™ to Treat Multiple Myeloma

Legend Biotech Corporation (Legend Biotech) announced that the U.S. Food and Drug Administration (FDA) has approved its first product, CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel), to treat adult patients with relapsed or refractory multiple myeloma (RRMM) who...

FDA Clearance: LBPs to Treat Parkinson’s Disease

FDA Clearance: LBPs to Treat Parkinson’s Disease

4D pharma plc announced that the FDA has cleared IND applications for two Live Biotherapeutics (LBPs), MRx0005 and MRx0029, for the treatment of Parkinson’s disease. Parkinson’s disease, which impacts more than 10 million people worldwide, is a progressive...

Swissmedic Approval: BeiGene’s BRUKINSA to Treat WM

Swissmedic Approval: BeiGene’s BRUKINSA to Treat WM

BeiGene has announced their Bruton’s tyrosine kinase (BTK) inhibitor BRUKINSA (zanubrutinib) has been approved by Swissmedic to treat adult patients with Waldenström’s macroglobulinemia (WM). WM is a rare B-cell lymphoma that is primarily found in bone marrow and...

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...