The Trump Administration has proposed a plan to reorganize the federal government, the Washington Post reports.
The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.
The FDA will consider the companion diagnostic application alongside data for Pfizer's talazoparib in BRCA-mutated advanced breast cancer.
The company is planning to submit the drug and a companion diagnostic that can identify patients with FGFR alterations with the FDA in the second half of 2018.
The Personalized Medicine Coalition defends the US Food and Drug Administration from criticism on its push to shorten the regulatory review process.
Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify cervical cancer patients who may benefit from the anti-PD1 immunotherapy.
Makers of genetic health risk tests will only need one FDA review before commercializing tests, with some exceptions.
This data is helping the agency understand how precision oncology drugs and tests are prescribed outside of clinical trials and in the broader cancer community.
The test is Micronics’ first to receive FDA clearance, and the company is pursuing CE marking for it and the PanNAT system.
Stat News reports that a sponsor of the US "right-to-try" bill says in a letter that it "intends to diminish the FDA's power."
A University of California, Los Angeles-led team has found turning off the CCR5 gene could improve recovery after a stroke, according to Scientific American.
South Dakota lawmakers are to weigh a bill aimed at teaching the strengths and weaknesses of scientific concepts, the Associated Press and KEVN-Black Hills Fox report.
In Science this week: the synthetic genetic system hachimoji, and more.
Thermo Fisher Scientific says it will no longer sell machines in China's Xinjiang region, according to the Wall Street Journal.