The U.S. Food and Drug Administration took action to help increase the supply of ventilators, ventilator tubing connectors, and ventilator accessories, as well as filtering facepiece respirators (FFRs) due to shortages during COVID-19, as part of our commitment to ease burdens on the health care system during this pandemic.
During this COVID-19 pandemic, the FDA is working around the clock to make sure that Americans have access to safe food and medical products.
Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that its Logix Smart™ Coronavirus COVID-19 Test has obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2.
EIDD-2801, an oral broad-spectrum antiviral proceeding into Clinical Trials
Halo Labs, a life science instrumentation company developing tools for biologics researchers, announced it has closed a $12M Series B1 financing round led by Research Corporation Technologies (RCT).
Future Use in Outbreak Management Expected, via DARPA Partnership
Amid COVID-19 pandemic, remote healthcare solutions are a priority now more than ever
Hand Sanitizer Utilizing FDA/CDC Approved Formula Begins Shipping this Week
FDA has declared the COVID-19 outbreak a public health emergency and implemented an expedited pathway to market authorization for products crucial in addressing this crisis, the Emergency Use Authorization (EUA).
Agency Continues Effort to Protect Public Health from Fraudulent and Harmful Products
Registration as an over-the-counter drug manufacturer to prepare alcohol-based hand sanitizers accelerates anticipated timeline to initial production
The Boston-based green chemistry company's trial will study the industry's first all-natural, silk-based dermal filler
The U.S. Food and Drug Administration issued the second emergency use authorization (EUA) to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings.
FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of July 23, 2020
Accurate Diagnostic Laboratories and RUCDR Infinite Biologics through its Clinical Genomics Laboratory are pleased to announce they have implemented a test that will allow virtually anyone to test for COVID-19
New Test Uses BD MAX™ System to Augment Supply from Existing Collaborations; Test Results in Under Three Hours
Centinel Spine®, LLC, the largest privately-held spine company focused on anterior column reconstruction, announced FDA approval of two-level indications for the prodisc® L Lumbar Total Disc Replacement (TDR) system.
Xenocor, Inc. announced the FDA cleared the new Xenocor Disposable 5mm Articulating Laparoscope for minimally invasive abdominal and thoracic surgery.
The U.S. Food and Drug Administration’s User Fee programs help us fulfill our mission to protect public health while also helping to accelerate innovation in industry and bring new treatment options to the American public.
The U.S. Food and Drug Administration announced a further expansion of COVID-19 testing options through the recognition that spun synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose.