Showing 2061-2070 of 5771 results for "".
- Liminal BioSciences Announces Resubmission of Biologics License Application to FDA for Ryplazimhttps://modernod.com/news/liminal-biosciences-announces-resubmission-of-biologics-license-application-to-fda-for-ryplazim/2478254/Liminal BioSciences announced that the company, through its U.S. subsidiary Prometic Biotherapeutics, has filed a resubmission of the biologics license application (BLA) for Ryplazim (plasminogen) (Ryplazim) with the FDA for the treatment of congenital plasminogen deficiency (C-PLGD). “The
- Alimera Sciences Announces Enrollment of First Patient in NEW DAY Clinical Trial to Evaluate Iluvien as Baseline Therapy for DMEhttps://modernod.com/news/alimera-sciences-announces-enrollment-of-first-patient-in-new-day-clinical-trial-to-evaluate-iluvien-as-baseline-therapy-for-dme/2478243/Alimera Sciences announces that it has enrolled the first patient in the company’s NEW DAY clinical trial, a randomized, controlled, multicenter study designed to generate prospective data for Iluvien (fluocinolone ac
- ReVision Therapeutics Announces License With Cornell to Develop Treatment for Stargardt Diseasehttps://modernod.com/news/revision-therapeutics-announces-license-with-cornell-to-develop-treatment-for-stargardt-disease/2478230/ReVision Therapeutics announced that it has signed an exclusive license agreement with Cornell University for the development and commercialization of Cornell’s proprietary technology for the treatment of Stargardt disease, a genetic d
- Mylan and Biocon Biologics Announce Launch of Semglee in the US for Patients With Diabeteshttps://modernod.com/news/mylan-and-biocon-biologics-announce-launch-of-semglee-in-the-us-for-patients-with-diabetes/2478220/Mylan and Biocon Biologics India announced the US launch of Semglee (insulin glargine injection) in vial and pre-filled pens, approved to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. It is not recommended for the treatment of
- Topcon Announces the US Launch of Aladdin-Mhttps://modernod.com/news/topcon-announces-the-us-launch-of-aladdin-m/2478217/Topcon Healthcare announced that it has launched its new Aladdin-M instrument in the US market. Aladdin-M combines corneal topography, pupillometry, and optical biometry to enable objective measurement of corneal curvature, pupil dynamics, and axial length metrics. The all-in-one Aladdin-M
- CooperVision Announces Direct-to-Consumer Campaign Featuring Sarah Michelle Gellarhttps://modernod.com/news/coopervision-announces-direct-to-consumer-campaign-featuring-sarah-michelle-gellar/2478209/CooperVision announced popular US television actress, producer, and entrepreneur Sarah Michelle Gellar as the spokesperson for its Brilliant Futures Myopia Management Program. Brilliant Futures is built around MiSight 1 day, the first and only soft contact lens FDA-approved to slow the progressio
- Sight Sciences Announces Positive Interim Results From Trial of the OMNI Surgical System in Open-Angle Glaucomahttps://modernod.com/news/sight-sciences-announces-positive-interim-results-from-trial-of-the-omni-surgical-system-in-open-angle-glaucoma/2478205/Sight Sciences announced positive 6-month interim safety and efficacy results from a prospective, multicenter, historically controlled clinical trial of the OMNI Surgical System in open-angle glaucoma (OAG). The OMNI Surgical System is currently cleared for use for the delivery of small amounts o
- Regenxbio Announces FDA Clearance of IND for Phase 2 Trial of RGX-314 for the Treatment of DR Using Suprachoroidal Deliveryhttps://modernod.com/news/regenxbio-announces-fda-clearance-of-ind-for-phase-2-trial-of-rgx-314-for-the-treatment-of-dr-using-suprachoroidal-delivery/2478202/Regenxbio announced the clearance of the investigational new drug (IND) application by the FDA to evaluate the suprachoroidal delivery of RGX-314 in patients with diabetic retinopathy (DR). The IND is active, and Regenxbio plans to begin dosing patients in a phase 2 trial, ALTITUDE, in the second
- Gyroscope Therapeutics Announces FDA Clearance of Orbit Subretinal Delivery Systemhttps://modernod.com/news/gyroscope-therapeutics-announces-fda-clearance-for-orbit-subretinal-delivery-system/2478198/Gyroscope Therapeutics announced that the FDA has granted 510(k) clearance for the Orbit Subretinal Delivery System (Orbit SDS). The Orbit SDS is indicated for microinjection into the subretinal space at the back of the eye. The microinjection procedure is designed to avoid damaging the structure
- AGTC Announces Publication of Preclinical Data that Support the Ongoing Clinical Development of Its XLRP Gene Therapy Programhttps://modernod.com/news/agtc-announces-publication-of-preclinical-data-that-support-the-ongoing-clinical-development-of-its-xlrp-gene-therapy-program/2478200/Applied Genetic Technologies Corporation (AGTC) announced that preclinical data validating the transgene (hRPGRco) that is being evaluated in the company’s ongoing phase 1/2 clinical trial in patients with X-lined retinitis pigmentosa (XLRP) have been published in the July 15, 2020 print issue of