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 …
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).
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 …
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 …
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 …
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 …
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 …
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).
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.
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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