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  • Regulatory NewsRegulatory News

    FDA Considers Label Changes for Keytruda, Opdivo and Yervoy

    The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors. Currently, the labels of Bristol-Myers Squibb’s Yervoy (ipilimumab), Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) have uveitis listed as a potential immune-mediated adverse reaction (AR), and four of the five FDA-approved anti-PD1 therapies’ labels...
  • Regulatory NewsRegulatory News

    BMS' Opdivo Wins UK EAMS Approval for Hodgkin's Lymphoma

    The Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday accepted Bristol-Myers Squibb's Opdivo (nivolumab) to its early access to medicines scheme (EAMS) to treat relapsed or refractory Hodgkin's lymphoma. Previously, MHRA granted access to Opdivo under EAMS for patients with certain types of lung cancer, kidney cancer and melanoma. Background In March 2014, MHRA announced it was launching EAMS, saying it would allow earlier access to potentially...
  • Regulatory NewsRegulatory News

    FDA Approves Modified Dosing Regimen for Bristol-Myers Squibb’s Cancer Treatment Opdivo

    The US Food and Drug Administration (FDA) has agreed to modify the dosage regimen for Bristol-Myers Squibb’s cancer treatment Opdivo (nivolumab) for the currently approved indications of renal cell carcinoma, metastatic melanoma and non-small cell lung cancer.  The modification of the “Dosage and Administration” section of the label replaces “the single dose regimen of nivolumab (3 mg/kg intravenously every two weeks) with the new recommended regimen of 240 mg IV every t...
  • Regulatory NewsRegulatory News

    Cancer Drugs First to Take Advantage of UK Early Access Scheme

    The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a second product under a new accelerated review process intended to make promising new drugs available to patients more quickly. The drug, Bristol Myers Squibb's Opdivo (nivolumab), joins Merck's Keytruda (pembrolizumab) as one of two products listed under MHRA's early access to medicines scheme (EAMS), both of which are intended to treat advanced melanoma. Background In March 2014, MHRA ann...