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  1. Withhold Opdivo SC for Grade 3 rash and permanently discontinue OPDIVO SC for Grade 4 rash. Administer corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents for …

  2. On December 27, 2024, the FDA announced the approval of Bristol Myers Squibb’s Opdivo Qvantig (nivolumab/hyaluronidase-nvhy), a subcutaneous (SC) formulation of Opdivo® (nivolumab).

  3. OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) as determined by an FDA-approved …

  4. SC formulation of nivolumab approved - epocrates Web

    Jan 7, 2025 · The SC injection of nivolumab and hyaluronidase-nvhy was evaluated in the multicenter, randomized, open-label CHECKMATE-67T trial (NCT04810078) involving patients …

  5. EC approves BMS’ nivolumab SC formulation for solid tumours

    May 29, 2025 · It received approval in 65 nations and regions, including the EU, China, Japan and the US. In May 2025, the company announced a significant investment plan, committing $40bn …

  6. Opdivo SC wins EC approval | The Pharmaletter

    Jun 2, 2025 · US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved a new Opdivo (nivolumab) formulation associated with a new …

  7. BMS’s Opdivo gains FDA approval for faster subcutaneous cancer ...

    Dec 31, 2024 · Earlier, the Swiss pharmaceutical company Roche was the first among immune anticancer drugs to receive subcutaneous approval in Europe last year, followed by the United …

  8. FDA to Review Subcutaneous Formulation of Nivolumab

    May 7, 2024 · The FDA is reviewing the biologics license application for a new subcutaneous formulation of Opdivo (nivolumab).

  9. FDA approves BMS' subcutaneous Opdivo with some limitations

    Jan 2, 2025 · Approved by the FDA in October, the indication allows Opdivo first to be used with chemotherapy—which comes as an IV—before surgery, and then as a monotherapy after surgery.

  10. FDA approves nivolumab and hyaluronidase-nvhy for …

    On December 27, 2024, the Food and Drug Administration approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb Company) for subcutaneous injection across …

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