Showing 1201-1210 of 1484 results for "".
- Nanoscope Secures EMA Orphan Designations and FDA RMAT Status for Retinal Gene Therapy MCO-010https://modernod.com/news/nanoscope-secures-ema-orphan-designations-and-fda-rmat-status-for-retinal-gene-therapy-mco-010/2484130/Nanoscope Therapeutics announced regulatory milestones in both Europe and the United States for its lead gene therapy candidate, MCO-010 (sonpiretigene isteparvovec). The European Medicines Agency (EMA) has granted Orphan D
- European Commission Approves Mynzepli as a Biosimilar to Eyleahttps://modernod.com/news/european-commission-approves-mynzepli-as-a-biosimilar-to-eylea/2484127/The European Commission has granted marketing authorization for Mynzepli (aflibercept), a biosimilar to Eylea, developed by Alvotech in partnership with Advanz Pharma. The centralized authorization applies t
- Sydnexis Announces European Commission Approval of Ryjunea, the First Treatment for Slowing the Progression of Pediatric Myopiahttps://modernod.com/news/sydnexis-announces-european-commission-approval-of-ryjunea-first-treatment-for-slowing-the-progression-of-pediatric-myopia/2482839/The European Commission (EC) has granted marketing authorization for Sydnexis' SYD-101 (branded as Ryjunea), the company’s proprietary low-dose atropine formulation, for slowing the progression of pediatric myopia.
- Formycon Receives EU Approval for Eylea Biosimilar FYB203 Under the Brand Names Ahzantive and Baiamahttps://modernod.com/news/formycon-receives-eu-approval-for-eylea-biosimilar-fyb203-under-the-brand-names-ahzantive-and-baiama/2482624/Formycon and its licensing partner Klinge Biopharma jointly announce that the European Commission has granted central marketing authorization for FYB203 (aflibercept), a biosimilar to Eylea, under the brand names Ahzantive and Baiama. The app
- Fera Pharmaceuticals Obtains Orphan Drug Designation from the FDA for Naproxcinod for the Treatment of Sickle Cell Diseasehttps://modernod.com/news/nicoxs-partner-fera-pharmaceuticals-obtains-orphan-drug-designation-from-the-us-fda-for-naproxcinod-for-the-treatment-of-sickle-cell-disease/2480673/Nicox SA and Fera Pharmaceuticals announced that the FDA has granted Orphan Drug Designation for naproxcinod for the treatment of sickle cell disease, which affects an estimated 100,000 Americans. Naproxcinod is a nitr
- Accure Therapeutics Licenses Neuroprotective Drug Candidate to Oculishttps://modernod.com/news/accure-therapeutics-licenses-neuroprotective-drug-candidate-to-ophthalmology-company-oculus/2480672/Oculis and Accure Therapeutics announced a licensing agreement granting Oculis exclusive global rights to develop and commercialize ACT-01, a potentially disease-modifying therapy to protect and prevent damage to the optic
- Aldeyra Therapeutics Receives Orphan Drug Designation from the FDA for ADX-2191 to Treat Retinitis Pigmentosahttps://modernod.com/news/aldeyra-therapeutics-receives-orphan-drug-designation-from-the-fda-for-adx-2191-to-treat-retinitis-pigmentosa/2479434/Aldeyra Therapeutics announced that the FDA has granted orphan drug designation for ADX-2191 (methotrexate for intravitreal injection) for the treatment of retinitis pigmentosa (RP). Methotrexate inhibits dihydrofolic reductase, an enzyme involved in cellular replication and activation. In
- FDA Sets January Deadline to Decide on Full Approval of Pfizer, BioNTech Vaccinehttps://modernod.com/news/fda-sets-january-deadline-to-decide-on-full-approval-of-pfizer-biontech-vaccine/2479380/Pfizer and BioNTech said that the FDA has granted a priority review for an application seeking full approval of their vaccine BNT162b2 to prevent COVID-19 in people 16 years and older, according to a FirstWord
- Health Canada Authorizes Enspryng for Canadians Living with Neuromyelitis Optica Spectrum Disorderhttps://modernod.com/news/health-canada-authorizes-enspryng-for-canadians-living-with-neuromyelitis-optica-spectrum-disorder/2478219/Roche Canada announced that Health Canada has granted market authorization for Enspryng (satralizumab) as monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult and adolescent patients who are anti-aqu
- Clearside Biomedical Expands Patent Portfolio in the US and Europehttps://modernod.com/news/clearside-biomedical-expands-patent-portfolio-in-the-us-and-europe/2478203/Clearside Biomedical announced the recent issuance of three additional patents in the United States and Europe. The United States Patent and Trademark Office (USPTO) recently granted patent number 10,722,396 to Clearside. This patent covers Clearside’s SCS M