ANI: Announces FDA Acceptance of Supplemental Filing for Cortrophin® Gel 80 U/mL
FDA Sets Prescription Drug User Fee Act (PDUFA) Goal Date of July 23, 2020
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ACCURATE DIAGNOSTIC LABORATORIES: EUA FDA Clears First Saliva Collection for Coronavirus COVID-19 (SARS-CoV-2), Made Possible by Collaborative Efforts of Accurate Diagnostic Labs and RUCDR Infinite Biologics at Rutgers University
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
BD: Announces Second FDA Emergency Use Authorization, CE Mark for New COVID-19 Molecular Diagnostic for Global Use
New Test Uses BD MAX™ System to Augment Supply from Existing Collaborations; Test Results in Under Three Hours
CENTINEL SPINE: Announces FDA Approval for Two-level prodisc® L Total Disc Replacement
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: FDA Clears New Disposable Fog-Free Articulating 5mm Laparoscope
Xenocor, Inc. announced the FDA cleared the new Xenocor Disposable 5mm Articulating Laparoscope for minimally invasive abdominal and thoracic surgery.
FDA: Coronavirus (COVID-19) Update: FDA Continues User-Fee Related Reviews Through COVID-19
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.
FDA: Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs
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.
CIRRUSDX LABORATORY: Receives Emergency Use Authorization from FDA for COVID-19 Testing
Cirrus Dx, Inc. (CirrusDx), an infectious disease laboratory and diagnostics company, received Emergency Use Authorization (EUA) from the US Food & Drug Administration (FDA) to perform SARS-COVID-19 testing.
VENT MULTIPLEXOR: Receives FDA Emergency Use Authorization for Crisis Care Co-Ventilation During COVID-19 Pandemic
Emergency rescue device developed by Vent Multiplexor LLC in collaboration with Yale New Haven Hospital is the first ever device designed to enable individualized ventilation care for two patients sharing a single mechanical ventilator.
FDA: Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19
Agency Continues Effort to Protect Public Health from Fraudulent and Potentially Harmful Products
FDA: Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts
Every step we have taken as part of our approach to COVID-19 testing has been a careful balancing of risks and benefits in order to meet the urgent public health needs as we combat this new pathogen.
LIFE SPINE: Announces FDA 510(k) Clearance of the PROLIFT® Lateral Fixated System
Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the PROLIFT Lateral Fixated System.
HOPE BIOSCIENCES: Announces Third FDA-approved Clinical Trial for COVID-19
Mesenchymal Stem Cells for Treatment of Hospitalized COVID-19 Patients
SEEGENE: Seegene's Allplex™ 2019-nCoV Assay receives FDA Emergency Use Authorization
Seegene, Inc. announced that U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its Allplex™ 2019-nCoV Assay, a Real-time RT-PCR test for SARS-CoV-2, the novel coronavirus responsible for the COVID-19 disease.
ABBVIE: IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
IMBRUVICA plus rituximab demonstrated superior progression-free survival against the chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR) for previously untreated patients with chronic lymphocytic leukemia (CLL)
FDA: Warns Companies Illegally Selling CBD Products to Treat Medical Conditions, Opioid Addiction
The U.S. Food and Drug Administration has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act).
VISCARDIA: Announces Its Novel Heart Failure Therapy Receives Breakthrough Device Designation From the FDA
VisCardia Inc., a privately held medical device developer, announced today it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its implantable VisONE® system designed for the treatment of moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony.
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BAXTER: Obtains U.S. FDA Emergency Use Authorization for Oxiris Blood Purification Filter for COVID-19 Treatment
Only filter set available in the U.S. to reduce pro-inflammatory cytokine levels in the blood, including use in continuous renal replacement therapy (CRRT), for confirmed COVID-19 cases admitted to the ICU with confirmed or imminent respiratory failure who require blood purification
FDA: Coronavirus (COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns
Agency Additionally Warns Consumers about Hand Sanitizer Sold with Fraudulent Claims