Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
Tonix Pharmaceuticals: Orphan Drug Designation for TNX-2900
Tonix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for TNX-2900 (intranasal potentiated oxytocin) to treat Prader-Willi syndrome. Prader-Willi syndrome is a rare genetic disorder that causes...
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
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 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...
Medtronic Launches NuVent™ Eustachian Tube Dilation Balloon
Medtronic plc has announced the launch of the NuVent™ Eustachian tube dilation balloon, which has been cleared by the U.S. Food and Drug Administration (FDA) for treating chronic, obstructive Eustachian Tube Dysfunction. The NuVent™ balloon serves as an alternative...
New Requirements for Clinical Trial Translations: EU-CTR Provisions to Informed Patient Consent
Within clinical trial translations, informed patient consent forms (ICFs) are an important and mandatory prerequisite for all submissions that not only represent the patient’s individual rights but also serve as an underlying principle of medical ethics. Under the...
FDA Clears Viz.ai’s Cerebral Aneurysm Detection Module
Viz.ai has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Viz ANEURYSM, a new algorithm that uses artificial intelligence (AI) to detect suspected cerebral aneurysms. The intention is to ensure that patients receive...
FDA Breakthrough Device Designation for Epilepsy Treatment
Precisis GmbH has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Epicranial Application of Stimulation Electrodes for Epilepsy (EASEE) brain stimulator to treat epilepsy. EASEE is a system for individualized brain...
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
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...
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