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BOX BIOSCIENCE: Works Overtime To Provide FDA Approved Sanitizer

BOX BioScience has formed a joint venture with Singlepoint (OTC: SING) to distribute hand sanitizer products manufactured out of Carlsbad, CA.

VITALCONNECT: FDA Grants Emergency Use Authorization to VitalConnect for Cardiac Monitoring in COVID-19 Patients

VitalPatch® wearable biosensor can monitor for heart-related side effects of Hydroxychloroquine and other COVID-19 treatments

FDA: Insight into FDA's Revised Policy on Antibody Tests: Prioritizing Access and Accuracy

By: Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA, and Jeff Shuren, M.D., Director, Center for Devices and Radiological Health

ALUME BIOSCIENCES: US FDA Allows Trial to Proceed for Alume Biosciences' Nerve Imaging Candidate

Phase 1/2 Clinical Trial for ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery Will Begin Enrollment at the University California San Diego (UCSD), Stanford and Harvard

SCIBASE: Receives FDA Approval for Nevisense 3.0

SciBase (SCIB) Stockholm, Sweden - announced today that it has received approval from the US Food and Drug Administration (FDA) for Nevisense 3.0, the third generation of their Nevisense system for early melanoma detection.

FDA: Coronavirus (COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator Emergency Use Authorization

The U.S. Food and Drug Administration included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19.

ALPHA COGNITION, INC.: Receives FDA/PMDA Regulatory Guidance for Alpha-1062 Alzheimer's Therapy

Alpha Cognition Inc. (ACI) today announced that in a pre-Investigational New Drug (Pre-IND) meeting, the U.S. Food and Drug Administration (USFDA) agreed upon a clinical and regulatory pathway for the approval of Alpha-1062, a patented new chemical entity, to treat Alzheimer's disease.

METHODSENSE: Creates Resource Website to Assist in Medical Device FDA Authorization Submissions

Morrisville, N.C., company provides resources and direction for medical device authorization under FDA Emergency Use Authorization Guidance.

ANI: Receives Refusal to File Letter from FDA for Cortrophin® Gel

ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Cortrophin® Gel.

LUNGPACER MEDICAL: Receives FDA Emergency Use Authorization for Novel, Non-implanted Device to Wean Patients Off Mechanical Ventilation During Covid Crisis

Lungpacer Medical announced today that the U.S. Food and Drug Administration has issued Emergency Use Authorization (EUA) for the Company's novel Diaphragmatic Pacing Therapy System (DPTS) for immediate use in patients on invasive mechanical ventilators at high risk of weaning failure, including COVID-19 patients.

CARIS LIFE SCIENCES: Submits Two PMA Applications to the FDA for Whole Exome and Whole Transcriptome Sequencing

Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced the submission of two Pre-Market Approval (PMA) applications for MI Exome™ CDx and MI Transcriptome™ CDx to the U.S. Food and Drug Administration (FDA).

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

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.

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)

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.

FDA Reporter