Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the development and advancement of immunology based therapies for prevalent inflammatory conditions, today announced the publication "Insights into pediatric multi-system inflammatory syndrome and COVID-19."
TCI GENE, a subsidiary of TCI Co., Ltd. (Ticker: 8436) that produces the MOHW-certified QVS-96 system delivered to Kunyang Laboratory, CDC, Taiwan, has been registered with U.S. FDA and qualified to sell the fully automated detection integration system in the U.S. With the high influence of the US FDA in the world, it is believed that FDA in many countries will refer to its standard for the certification of the system, and it is expected that the system will be installed in major airports around the world to support epidemic prevention and help restore high traffic for economic recovery.
If approved, terlipressin would be the first FDA-approved treatment in the United States for adult patients with HRS-1, a life-threatening condition
Advisory committee meeting scheduled for July 15, 2020
U.S. Food and Drug Administration further assisted health care providers around the country prepare for the upcoming flu season during the COVID-19 pandemic by issuing an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 by their healthcare provider to the U.S. Centers for Disease Control and Prevention (CDC).
Qualigen expects sales and shipments of the new test to begin in mid-July.
In a webinar for Fragrance Creators members, FDA delivered detailed instructions on registration and listing of hand sanitizers under the Agency's temporary guidance
Protagonist Therapeutics, Inc. (Nasdaq: PTGX) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for PTG-300 for the treatment of polycythemia vera.
Full Results from Phase 2 WILLOW Study of Brensocatib in NCFBE to be Presented at Virtual ATS Session on June 24, 2020
Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health"), announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for BAUSCH + LOMB INFUSE™ daily disposable silicone hydrogel (SiHy daily) contact lenses.
Beckman Coulter Life Sciences today announced RNAdvance Viral XP has been added to the list of acceptable extraction methods for use in the Centers for Disease Control's EUA-authorized COVID-19 test referenced in the FDA's FAQ on testing for SARS-CoV-2.
U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
Lab Testing, in Combination with AI-Building Data Collection, Expected to Improve Predictive Power of Antibodies in Pandemic Response
Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application of avapritinib for the treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST).
If approved, AR19 would be the first-ever FDA-approved ADHD stimulant medication designed to resist manipulation for nonmedical use, which may help to deter misuse and abuse by intranasal, intravenous and smoking routes of administration
First of its kind AI-guided imaging supports assessment of cardiac function and decreases personnel exposure to novel Coronavirus
Fast Track Designation Highlights the Urgent Need for New Heart Failure Treatment Options