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regulatory approval

The test, when used as intended, allows doctors to gauge the magnitude of benefit melanoma patients might derive from the immunotherapeutic Opdivo.

The Associated Press reports that the US Food and Drug Administration approved 45 new drugs last year.

Two editors at The Verge discuss investment into 'disruptive' healthcare companies.

Genentech's Alecensa and AstraZeneca's Tegrisso are the latest precision lung cancer drugs, and Xalkori might soon be an option for a new molecular subpopulation.

Roche has received regulatory clearance to finalize its acquisition of Kapa Biosystems, the company announced this week.

The firm can now market its complete slate of diagnostic tests in New York. It also offers array-based tests for pregnancy loss and prenatal diagnosis.

Both tests analyze tumor and normal samples by next-generation sequencing to help doctors make therapy decisions for cancer patients.

FDA has approved BMS' Opdivo with a test to guide treatment strategies, but according to the drug label testing isn't required to identify who should receive the drug.

Scientists from The Francis Crick Institute have applied to UK regulators to use CRISPR/Cas9 genome editing in an upcoming study of miscarriage.

Just Easier This Way

Forbes' Matthew Herper reports that the US Food and Drug Administration is approving more drugs than not.


The US Department of Justice has proposed a rule change to enable DNA to be collected from migrants, the Associated Press reports.

Bernard Fisher, a surgeon who changed how breast cancer is treated, has died at 101, the New York Times reports.

Washington Post columnist writes that she is skeptical about DNA-based diets.

In PNAS this week: recurrent inactivation of DEPDC5 in gastrointestinal stromal tumors, taxonomic reliability of GenBank sequences, and more.