Showing 1221-1230 of 1484 results for "".
- Sanofi’s Intravitreal Gene Therapy Earns FDA Fast Track Designation for Geographic Atrophyhttps://modernod.com/news/sanofis-intravitreal-gene-therapy-earns-fda-fast-track-designation-for-geographic-atrophy/2482888/The FDA has granted fast track designation to SAR446597, a one-time intravitreal gene therapy for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD). The fast track designation process aims to facilitate the developm
- Formycon and Bio Usawa Partner Bio to Provide FYB201/ BioUcenta (Ranibizumab) Across Sub-Saharan Africahttps://modernod.com/news/formycon-and-bio-usawa-partner-bio-to-provide-fyb201-bioucenta-ranibizumab-across-sub-saharan-africa/2482870/Formycon announced a partnership between Bioeq AG—licensee and exclusive global commercialization rights holder for Formycon’s biosimilar FYB201—and African biotechnology company Bio Usawa Biotechnology. The agreement grants Bio Usawa exclusiv
- The European Commission (EC) Approves Eylea 8 mg for Extended Treatment Intervals of Up to 6 Monthshttps://modernod.com/news/the-european-commission-ec-approves-eylea-8-mg-for-extended-treatment-intervals-of-up-to-6-months/2482867/The European Commission (EC) has granted a label extension in the European Union (EU) for Eylea 8 mg with extended treatment intervals of up to 6 months for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Eylea 8 mg was previously
- Sydnexis Announces Positive CHMP Opinion in Europe for Myopia Drug Candidate SYD-101https://modernod.com/news/sydnexis-announces-positive-chmp-opinion-in-europe-for-myopia-drug-candidate-syd-101/2482722/Sydnexis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for its proprietary low-dose atropine formulation, SYD-101, for slowing the progression of pediatric m
- ViGeneron Announces FDA Rare Pediatric Disease Designation for VG901; DSMB Approval to Advance Dose Escalation in Phase 1b RP Trialhttps://modernod.com/news/vigeneron-announces-fda-rare-pediatric-disease-designation-for-vg901-dsmb-approval-to-advance-dose-escalation-in-phase-1b-rp-trial/2482601/ViGeneron announced two important milestones for its novel gene therapy candidate VG901 to treat patients with retinitis pigmentosa (RP) caused by mutations in the CNGA1 gene. The FDA granted Rare Pediatric Disease Designation (RPD
- Alkeus Secures Rare Pediatric Disease and Fast Track FDA Designations for Gildeuretinol in Stargardt Diseasehttps://modernod.com/news/alkeus-secures-rare-pediatric-disease-and-fast-track-fda-designations-for-gildeuretinol-in-stargardt-disease/2482549/Alkeus Pharmaceuticals announced that its investigational oral therapy, gildeuretinol (ALK-001), has been granted Rare Pediatric Disease and Fast Track designations by the FDA for the treatment of Stargardt disease. “Stargardt disease imposes a relentless burden, robbing chil
- Samsung Bioepis and Biogen Announce EC Approval of Eylea Biosimilar Opuvizhttps://modernod.com/news/samsung-bioepis-and-biogen-announce-ec-approval-of-eylea-biosimilar-opuviz/2482545/Samsung Bioepis and Biogen jointly announced that the European Commission (EC) has granted approval for Opuviz 40 mg/mL for injection in a vial. The biosimilar, also known as SB15, references the established treatment Eylea (aflibercept) and was developed by Samsung Bioepis. T
- FELIQS Receives FDA Fast Track Designation for FLQ-101, a First-in-Class Small Molecule to Prevent Retinopathy of Prematurityhttps://modernod.com/news/feliqs-receives-fda-fast-track-designation-for-flq-101-a-first-in-class-small-molecule-to-prevent-retinopathy-of-prematurity/2482526/FELIQS announced that the US Food and Drug Administration (FDA) has granted its lead asset, FLQ-101, Fast Track designation for the prevention of retinopathy of prematurity (ROP). The company plans to conduct a Phase1b/2 study of FLQ-101 (tROPhy-1 study) both in the United States and Ja
- LumiThera Obtains FDA Authorization of Valeda Treatment for Dry AMDhttps://modernod.com/news/lumithera-obtains-fda-authorization-of-valeda-treatment-for-dry-amd/2482525/The FDA has granted authorization to LumiThera allowing the company to market its Valeda Light Delivery System. This approval, made under the De Novo authorization pathway, makes Valeda the first FDA-authorized device to treat vision loss in patients with dry AMD.
- Scientists at Medical College of Georgia Explore New Treatment Target for Diabetic Retinopathyhttps://modernod.com/news/scientists-at-medical-college-of-georgia-explore-new-treatment-target-for-diabetic-retinopathy/2482442/Researchers at the Medical College of Georgia at Augusta University are on a mission to find a new treatment target for diabetic retinopathy. With a $1.5 million grant from the National Eye Institute, vascular and endothelial biologist Shruti Sharma, PhD, and a team from the MCG C