Novartis to Start Large, Randomized Trial of Hydroxychloroquine in Hospitalized COVID-19 Patients
Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical ...
Tag: Emergency Use Authorization
Hydroxychlorquine and Azythromycine Combination Treatment for COVID-19 Can Raise Risk for Dangerous Abnormal Heart Rhythms
Hydroxychlorquine and Azythromycine Combination Treatment for COVID-19 Can Raise Risk for Dangerous Abnormal Heart Rhythms Cardiologists from Oregon Health & ...
COVID-19 Tests: How They Work and What’s in Development
One of the key factors in tackling the spread of COVID-19 across the globe is testing. In South Korea, for ...
FDA Allows Emergency Use of Investigational Convalescent Plasma for Critical COVID-19 Patients
The FDA is facilitating access to convalescent plasma, antibody-rich blood products that are taken from blood donated by people who ...
FDA Grants Emergency Use Authorization to Roche for SARS-CoV-2 Test
The world's largest biotech company today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use ...
FDA Issues Flexible New Policy to Help Expedite Availability of COVID-19 Diagnostics
The U.S. Food and Drug Administration today issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus ...
Secretary Azar Declares Public Health Emergency for United States for 2019 Novel Coronavirus
Health and Human Services Secretary Alex M. Azar II declared a public health emergency for the entire United States to aid ...
Revocation of Emergency Use Authorizations of Zika, Ebola Diagnostics
OraSure and DiaSorin diagnostics received other classifications for use which removed them from EUA eligibility. The following is a summarized ...
Project BioShield: Building a Better Medical Countermeasure Pipeline
Project BioShield has revolutionized the way the United States addresses health security threats, developing essential public-private partnerships for medical countermeasure ...
In Fight Against Superbugs, BARDA Looks to Shore Up National Stockpile Countermeasures
A crisis has arisen from the simultaneous decrease in the number of pharmaceutical companies developing antibiotics and the dramatic increase ...
FDA Authorizes Marketing of First Diagnostic Test for Zika Virus Antibodies
The marketing authorization does not impact the availability of the 14 other Zika nucleic acid diagnostics available under EUAs. Today, ...
FDA and DoD Sign Memorandum to Enhance Engagement on Medical Products for Servicemembers
Today, the U.S. Food and Drug Administration and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum ...
Mobile Diagnostic: FDA Authorizes Use of First Ebola Fingerstick Test with Portable Reader
The U.S. Food and Drug Administration announced on 9 Nov that an emergency use authorization (EUA) has been issued for ...
HHS Secretary Price Authorizes Emergency Use of Nerve Agent Antidotes
Secretary of Health and Human Services (HHS) Tom Price last week issued a “Determination and Declaration Regarding Emergency Use of ...
CDC Awards Up to $1 Billion for BioThrax Deliveries to Strategic National Stockpile
Emergent BioSolutions Inc. this week announced that the U.S. Department of Health and Human Services (HHS) is advancing its anthrax ...
BARDA Backs Biodosimetry Tests from MRIGlobal, DxTerity Diagnostics
To help save as many people as possible in the event of a large-scale nuclear or radiological emergency, the U.S. ...
DTRA-Backed Ebola Vaccine Moves Closer to Being Licensed
The unprecedented Ebola epidemic in West Africa first broke out in Guinea in March 2014, and quickly spread to neighboring ...
NuThrax: HHS Backs Next-Gen Anthrax Vaccine with 198M Contract
The U.S. Department of Health and Human Services has awarded a new contract to Emergent Biosolutions to support advanced development ...
Quest Diagnostics Launches Zika Antibody Test Service
Quest Diagnostics today announced the availability of a new antibody test service that aids the diagnosis of infection with the ...
BARDA Backs OraSure’s Rapid Zika Diagnostic
The U.S. federal government last week announced an award to OraSure Technologies, Inc. to fund the evaluation of additional product ...
