Showing 1091-1100 of 1484 results for "".
- Atsena Granted FDA Fast Track Designation for Gene Therapy to Treat X-linked Retinoschisishttps://modernod.com/news/atsena-therapeutics-granted-fda-fast-track-designation-for-gene-therapy-to-treat-x-linked-retinoschisis/2482699/Atsena Therapeutics announced that the FDA has granted Fast Track designation for gene therapy product candidate, ATSN-201, for the treatment of X-linked retinoschisis (XLRS). ATSN-201 leverages AAV.SPR, the company’s novel spreading capsid, to achieve therapeutic levels of g
- Nacuity Pharmaceuticals Granted FDA Fast Track Designation for NPI-001 Tablets for RPhttps://modernod.com/news/nacuity-pharmaceuticals-granted-fda-fast-track-designation-for-npi-001-tablets-for-retinitis-pigmentosa/2482625/Nacuity Pharmaceuticals announced that the FDA has granted Fast Track Designation to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s proprietary investigational therapy for the treatment of patients with retinitis pigmentosa (RP). A drug may receive Fast Track designation
- Atsena Therapeutics Granted FDA Orphan Drug Designation for Gene Therapy Targeting XLRShttps://modernod.com/news/atsena-therapeutics-granted-fda-orphan-drug-designation-for-gene-therapy-targeting-x-linked-retinoschisis/2482443/The FDA has granted Orphan Drug Designation to Atsena Therapeutics' product candidate, ATSN-201, which is designed for the treatment of X-linked retinoschisis (XLRS). This gene therapy utilizes the company’s AAV.SPR capsid technology, which enables targeted gene expression in the p
- FDA Grants DeNovo Classification to Balance Ophthalmics' FYSX Ocular Pressure Adjusting Pumphttps://modernod.com/news/fda-grants-denovo-classification-to-balance-ophthalmics-fysxtm-ocular-pressure-adjusting-pump/2482333/Balance Ophthalmics announced that the FDA has granted DeNovo Classification of the FYSX Ocular Pressure Adjusting Pump, a new category of treatment for patients with normal tension glaucoma (NTG) and open-angle glaucoma (OAG) with IOP ≤ 21 mmHg. “The FDA classif
- FDA Grants Notal Vision Home OCT System De Novo Marketing Authorizationhttps://modernod.com/news/fda-grants-notal-vision-home-oct-scanly-de-novo-marketing-authorization/2482282/Notal Vision announced that the FDA has granted De Novo authorization for its patient self-operated Scanly Home OCT device. Designated by the FDA as a breakthrough device for patients suffering from wet age-related macular degeneration (AMD), Scanly Home OCT aims to improve persona
- FDA Grants Breakthrough Device Status to Toku’s Patented Cardiovascular Risk AI (CLAiR) Platformhttps://modernod.com/news/fda-grants-breakthrough-device-status-to-tokus-patented-cardiovascular-risk-ai-clair-platform/2481934/Toku announced that the FDA has granted Breakthrough Device designation to its patented CLAiR technology. According to Toku, the CLAiR platform, if cleared by the FDA, will be the first medical device in the US market that can provide affordable, point-of-care and non-invasive
- Delta Gamma Foundation Awards RestoringVision with Grant to Serve People in Need of Vision Services and Eyeglasses in the UShttps://modernod.com/news/delta-gamma-foundation-awards-restoringvision-with-grant-to-serve-people-in-need-of-vision-services-and-eyeglasses-in-the-us/2481609/RestoringVision, a global nonprofit, recently won its third Service for Sight grant from the Delta Gamma Foundation. The funding will support bringing vision services and eyeglasses to 270,000 low-income people in the United States, according to RestoringVision. The award supports
- FDA Grants Breakthrough Therapy Designation for Iveric Bio's Avacincaptad Pegol for Geographic Atrophyhttps://modernod.com/news/fda-grants-breakthrough-therapy-designation-for-iveric-bios-avacincaptad-pegol-for-geographic-atrophy/2481251/Iveric bio announced that the FDA has granted Breakthrough Therapy designation for avacincaptad pegol (ACP, also known as Zimura), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). To date, A
- Adverum Biotechnologies Granted Priority Medicines (PRIME) Designation by European Medicines Agency for ADVM-022 in Wet AMDhttps://modernod.com/news/adverum-biotechnologies-granted-priority-medicines-prime-designation-by-european-medicines-agency-for-advm-022-in-wet-amd/2480943/Adverum Biotechnologies announced that the European Medicines Agency (EMA) has granted ADVM-022 Priority Medicines (PRIME) designation for the treatment of wet age-related macular degeneration (AMD). Adverum’s lead gene therapy candidate, ADVM-022, is a one-time, intr
- Amydis Receives NIH Grant to Develop a Novel Tau Retinal Tracer for Alzheimer’s Diseases and Other Tauopathieshttps://modernod.com/news/amydis-receives-nih-grant-award-to-develop-a-novel-tau-retinal-tracer-for-alzheimers-diseases-and-other-tauopathies/2479481/Amydis announced a new phase 1 grant award from the National Institute of Aging at the National Institutes of Health (NIH) to support the development of a novel small-molecule retinal tracer targeting the biomarker tau for the detection and diagnosis of Alzheimer’s disease and other tauopathies.<