Search Results for Opdivo

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FDA Considers Label Changes for Keytruda, Opdivo and Yervoy By Zachary Brennan - Published 12 July 2017

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.

Categories: News, US, FDA, Drugs, Postmarket surveillance

Tags: Opdivo, Keytruda, Yervoy, B-MS, Merck, uveitis

BMS' Opdivo Wins UK EAMS Approval for Hodgkin's Lymphoma By Michael Mezher - Published 03 November 2016

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.

Categories: News, Europe, MHRA, Biologics and biotechnology, Submission and registration

Tags: EAMS, Early Access to Medicines Scheme, Opdivo, Nivolumab, Hodgkin's Lymphoma

FDA Approves Modified Dosing Regimen for Bristol-Myers Squibb’s Cancer Treatment Opdivo By Zachary Brennan - Published 15 September 2016

The US Food and Drug Administration (FDA) this week agreed to modify the dosage regimen for Bristol-Myers Squibb’s cancer treatment Opdivo (nivolumab) for the currently approved indications for renal cell carcinoma, metastatic melanoma and non-small cell lung cancer. 

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Labeling

Tags: Opdivo, Bristol-Myers Squibb, Opdivo dosing

Cancer Drugs First to Take Advantage of UK Early Access Scheme By Michael Mezher - Published 03 June 2015

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.

Categories: News, Europe, MHRA, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy, Reimbursement

Tags: Early access to medicines scheme, EAMS, Keytruda, Opdivo, promising innovative medicine, PIM