vusolimogene oderparepvec

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News(5)

• Third time’s the charm for Replimune as melanoma drug earns FDA greenlight
  Replimune’s immunotherapy for advanced melanoma faced a perilous regulatory road with two previous rejections, but the drug—to be marketed as Tudriqev—prevailed with strong support from oncologists…
  biospace · 4d ago
• FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
  The U.S. Food and Drug Administration today granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy for the treatment of advanced,…
  fda_press · 4d ago
• Replimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapy
  The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10 to 3 in favor of Replimune’s immunotherapy for advanced melanoma in combination with Bristol Myers Squibb’s Opdivo, but tri…
  biospace · 11d ago
• Replimune’s twice-rejected melanoma drug prevails in FDA adcomm
  Following a pair of FDA rejections of its melanoma drug, Replimune’s fortunes flipped today after an advisory committee voted 10 to 3 in favor of the candidate’s effectiveness.
  fiercebiotech · 11d ago
• FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm
  The FDA's rebuff of Replimune comes a day after the agency similarly called into question the Phase 3 trial for Capricor’s Duchenne muscular dystrophy cell therapy.
  biospace · 13d ago