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Top targetedonc.com News

FDA · United StatesThe FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license application for vusolimogene oderparepvec in combination with nivolumab for the treatment of advanced melanoma.According to a company press release, the letter indicates that the FDA cannot approve the application for vusolimogene oderparepvec (RP1) — the company’s leadSee the Story
FDA Rejects RP1 for Advanced Melanoma, Says IGNYTE Not a ‘Well-Controlled’ Trial
67% Center coverage: 3 sources

United States · United StatesZydus Lifesciences Ltd has been tentatively approved by the USFDA for its generic Ibrutinib tablets. These tablets, used to treat blood cancers, will be manufactured in Ahmedabad. According to IQVIA data, the Ibrutinib market generated USD 2.15 billion in the US in 2025.See the Story
Zydus Lifesciences Secures Tentative FDA Nod for Generic Cancer Drug
100% Center coverage: 2 sources

United States · United StatesZydus Lifesciences Ltd has been tentatively approved by the USFDA for its generic Ibrutinib tablets. These tablets, used to treat blood cancers, will be manufactured in Ahmedabad. According to IQVIA data, the Ibrutinib market generated USD 2.15 billion in the US in 2025.See the Story
Zydus Lifesciences Secures Tentative FDA Nod for Generic Cancer Drug
100% Center coverage: 2 sources