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).
Phase 1 Dose-Escalation Trial in Therapy-Refractory Solid Tumors to Begin in 2020
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.
Dermapose Access enables quick and easy fat removal for transfer
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.
Morrisville, N.C., company provides resources and direction for medical device authorization under FDA Emergency Use Authorization Guidance.
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.
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.
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.
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
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
VitalPatch® wearable biosensor can monitor for heart-related side effects of Hydroxychloroquine and other COVID-19 treatments
BOX BioScience has formed a joint venture with Singlepoint (OTC: SING) to distribute hand sanitizer products manufactured out of Carlsbad, CA.
New large catheter platform FDA cleared to remove blood clots from peripheral vessels
DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP) and a leading provider of simulation and modeling software for pharmaceutical safety and efficacy, today announced that the U.S. Food and Drug Administration (FDA) has again renewed its multi-seat license for the company’s leading quantitative systems toxicology (QST) modeling software, DILIsym®.
U.S. Food and Drug Administration is providing an update on the agency’s efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic.
OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. (NASDAQ: IDXX), announced that the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the OPTI® SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus that causes COVID-19.
Demand for antibody tests continues to grow as Texas reopens economy
U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers – in patients whose tumors have an alteration (mutation or fusion) in a specific gene (RET or "rearranged during transfection"). Retevmo is the first therapy approved specifically for cancer patients with the RET gene alterations.
Abbott announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's SARS-CoV-2 IgG lab-based serology blood test on the Alinity™ i system.