360 Dx published announcement 01.25.2024, that the diagnostic laboratory research company, DiaSorin, has submitted a new test for the early identification of Lyme disease, for approval by US Food and Drug Administration (FDA).The Liaison LymeDetect test, an immunoassay, was developed in partnership with Qiagen.
HHS/Food & Drug Administration (FDA)
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
Articles in this section will include approvals for treatments, vaccines, and other items related to the prevention, treatment and cure of Lyme and other tick-borne diseases.
JAMA Network, 12.08.2023, published, “State-Regulated Psychedelics on a Collision Course With FDA.” In this online viewpoint article, Mason Marks, MD, JD, discusses that the Food and Drug Administration (FDA) may soon approve psychedelics for treating conditions of depression, posttraumatic stress disorder, and other indications, but that psychedelics are currently considered Schedule I controlled substances with high potential for abuse; and are currently not accepted for medical use.
The FDA has just announced that they plan to postpone their scheduled advisory committee meeting on Pfizer’s COVID-19 vaccine for children ages 6 months to 4 years. They do not […]
Pfizer has received priority review for their vaccine, TicoVac, that protects against tick-borne encephalitis. This tick-borne virus can cause meningitis and trigger long-term neurological symptoms. If approved, the vaccine would potentially protect travelers as well as members of the US military that are deployed to regions where the virus is common, such as Europe and parts of Asia.
First announced at the HHS Tick-Borne Disease Working Group’s (TBDWG) September 22 meeting, the Centers for Disease Control (CDC), in a Capitol Hill Announcement, presented plans to join with five […]