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...
LEXEO Therapeutics: IND Clearance for LX2006 AAV-based Gene Therapy
The US Food and Drug Administration (FDA) has cleared LEXEO Therapeutics’ Investigational New Drug (IND) application for LX2006, an adeno-associated virus (AAV)-based gene therapy candidate to treat Friedreich’s ataxia cardiomyopathy (FA cardiomyopathy). FA...
Tandem Diabetes Care: FDA Clearance for Insulin Pump Using Mobile App
Tandem Diabetes Care today announced a US Food and Drug Administration (FDA) clearance of a bolus insulin dosing feature on the t:slim X2 insulin pump using the t:connect mobile app. This case is the first-ever FDA-cleared smartphone application capable of initiating...
AffaMed: IND Clearance for AM712 to Treat Retinal Diseases
AffaMed Therapeutics’ Investigational New Drug (IND) application for the clinical development of AM712 (ASKG712), a novel proprietary bispecific biologic molecule, has been cleared by the US Food and Drug Administration (FDA). AM712 has been designed to treat retinal...
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...
European Union Clinical Trials Regulation (EU-CTR 536/2014)
On 31 January 2022, the anticipated European Union (EU) Clinical Trials Regulation 536/2014 (EU-CTR) came into effect, replacing the long-standing European Union Clinical Trials Directive 2001/20/EC (EU-CTD) legislation that regulates the clinical trial landscape in...
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...