EMA
NewStem Files FDA De Novo Submission, Gets CE Mark for Stem Cell Mutational Analysis Software
The NewStem Software Diagnostic Device screens human haploid embryonic stem cells for gene mutations involved in chemotherapy resistance.
MGI Receives CE Mark, Regulatory Clearance in Asia-Pacific Countries for Several Sequencers
The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.
Dako Declares CE Mark for PD-L1 Companion Diagnostic for Lung Cancer Immunotherapy
The test will identify NSCLC patients with PD-L1 expression who are likely to benefit from Merck's Keytruda, which has received a positive opinion from European regulators.
The European Medicines Agency announced it would launch an in-depth review of the benefits and risks of the leukemia medicine Iclusig (ponatinib).
Takeda, Zinfandel Evaluate Genetic Risk Algorithm Ahead of Alzheimer's Delay Study with Diabetes Rx
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Originally published July 23.
Feb 22, 2012
Nov 30, 2011