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Home Industry News & Regulatory Approvals

Breaking News Briefs

on: June 01, 2017In: Industry News & Regulatory Approvals
Breaking News Briefs

• Pembrolizumab (Keytruda) received FDA approval for use in combination with pemetrexed and carboplatin for the first-line treatment of patients with metastatic nonsquamous NSCLC, irrespective of PD-L1 expression. This approval […] Read more


Breaking News Briefs

on: April 01, 2017In: Industry News & Regulatory Approvals
Breaking News Briefs

• The global, randomized phase III ALEX study was announced to have met its primary endpoint, demonstrating that alectinib (Alecensa), as an initial (first-line) treatment, significantly reduced the risk of […] Read more

Breaking News Briefs

on: February 01, 2017In: Industry News & Regulatory Approvals
Breaking News Briefs

Alectinib (Alecensa) received a positive opinion from the European Medicines Agency (EMA) for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with advanced anaplastic lymphoma kinase […] Read more

Breaking News Briefs

on: November 01, 2016In: Industry News & Regulatory Approvals
Breaking News Briefs

RECENT APPROVALS: Pembrolizumab (Keytruda) was approved by the FDA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1. The following indications for pembrolizumab […] Read more

Breaking News Briefs

on: September 01, 2016In: Industry News & Regulatory Approvals
Breaking News Briefs

• Everolimus (Afinitor) has been approved by the European Commission for treatment of unresectable or metastatic, well-differentiated (grade 1 or grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or […] Read more

Breaking News Briefs

on: June 01, 2016In: Industry News & Regulatory Approvals
Breaking News Briefs

• Clovis Oncology is shutting down patient enrollment in clinical trials of its lung cancer drug rociletinib, which targets T790m, a mutation responsible for acquired resistance in more than half […] Read more

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