Search Results for Keytruda

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FDA Alerts on Risks From Merck’s Keytruda in Multiple Myeloma Following Halted Trials By Zachary Brennan - Published 31 August 2017

The US Food and Drug Administration (FDA) on Thursday released an alert and summary of findings from two halted Merck clinical trials evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Crisis management, Drugs

Tags: Keytruda, Merck, multiple myeloma, FDA alert

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

A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker By Zachary Brennan - Published 23 May 2017

The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Keytruda, Merck, biomarkers, oncology approvals

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

UK Regulator Issues First Positive Opinion in Early Access Program By Michael Mezher - Published 11 March 2015

Merck’s new skin cancer treatment has become the first product approved under a new accelerated review process by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

Categories: News, Europe, MHRA, Clinical, Drugs, Regulatory strategy, Submission and registration

Tags: Early Access to Medicines Scheme, EAMS, Keytruda, Advanced melanoma