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European Commission Approved DARZALEX Faspro® for Adult Patients with Smouldering Multiple Myeloma

European Commission Approved DARZALEX Faspro® for Adult Patients with Smouldering Multiple Myeloma

100% Center coverage: 3 sources

/PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company,...See the Story

FDA Rejects RP1 for Advanced Melanoma, Says IGNYTE Not a ‘Well-Controlled’ Trial

FDA · United States

FDA Rejects RP1 for Advanced Melanoma, Says IGNYTE Not a ‘Well-Controlled’ Trial

67% Center coverage: 3 sources

The 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 lead See the Story

Zydus Lifesciences Secures Tentative FDA Nod for Generic Cancer Drug

United States · United States

Zydus Lifesciences Secures Tentative FDA Nod for Generic Cancer Drug

100% Center coverage: 2 sources

Zydus 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

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