The approval by the Food and Drug Administration of 23andMe’s BRCA test is bound to create a discussion about the merits and pitfalls of direct to consumer genetic testing for cancer risk. It is also going to add fuel to a growing fire...Show More Summary
GOOD: FDA approves new medication for drug-resistant HIV.
(Washington University School of Medicine) The FDA recently approved the first cellular immunotherapies to treat certain blood cancers. But so far, these T cell immunotherapies can't be used if the T cells themselves are cancerous. Such 'CAR-T' cells kill each other because they resemble one another so closely. Show More Summary
The FDA recently approved the first cellular immunotherapies to treat certain blood cancers. But so far, these T cell immunotherapies can't be used if the T cells themselves are cancerous. Such 'CAR-T' cells kill each other because they resemble one another so closely. Show More Summary
(WASHINGTON) — U.S. regulators have approved the first direct-to-consumer breast cancer gene test. But the Food and Drug Administration said Tuesday it will require warnings about the limitations of the genetic information from California-based 23andMe. The test, which analyzes DNA from saliva, can only detect three out of more than 1,000 known inherited BRCA gene…
The FDA is approving artificial-intelligence software to help diagnose diseases and help treat patients.
Medtronic today announced that the FDA has approved a new arm indication for the Guardian Sensor 3, the company’s most accurate continuous glucose monitoring system and the only sensor approved in the U.S. to help control automated insulin delivery for patient with diabetes via its hybrid closed loop system – the MiniMed 670G system. This... Read More
(Reuters) - KemPharm Inc said on Friday the U.S. Food and Drug Administration approved its opioid painkiller Apadaz for the short-term management of acute pain, sending the shares of the drugmaker up as much as 36 percent in late afternoon trading.
On February 14th, the U.S. Food and Drug Administration (FDA) approved a blood test that has been proposed to diagnose concussion. Many media outlets quickly reported this announcement as being a breakthrough in concussion diagnosis...
(Reuters) - KemPharm Inc said on Friday the U.S. Food and Drug Administration approved its opioid painkiller Apadaz for the short-term management of acute pain.
The FDA approved a "historic" new cancer treatment for kids with leukemia, but it carries a big price tag.
(Scripps Research Institute) 'These results lay the groundwork for the next steps toward FDA approval,' says John Griffin, PhD, professor at TSRI, whose team invented 3K3A-APC.
(Reuters) - The U.S. Food and Drug Administration on Friday granted approval for expanded use of AstraZeneca Plc's, immunotherapy drug, Imfinzi, to treat non-small cell lung cancer whose tumors can't be surgically removed.
The FDA has approved a concussion blood test, which can diagnose a concussion within 12 hours of an injury, without exposure to radiation. The FDA Has Approved the First Ever Blood Test for Concussions is a post from Mommyish - Parenting Imperfect.
(Reuters) - The U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences Inc's Vitaros, a cream to treat erectile dysfunction, for the second time in a decade, sending the company's shares down more than 70 percent before the opening bell.
The FDA this week approved a blood test that quickly and reliably detects signs of a concussion. The new Banyan Brain Trauma Indicator exam will help eliminate needless and costly computed tomography (CT) […] The post FDA Approves Blood Test to ID Concussions appeared first on Geek.com.
From private biotech Banyan Biomarkers.
HEALTH: FDA approves first blood test that can help diagnose a concussion.
U.S. drug regulators want to let drugmakers test Alzheimer's disease treatments on patients years before the disease shows outward signs, and could approve the therapies based on subtle biological signals rather than proof they alleviate symptoms. The Food and Drug Administration proposal will...