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168 articles with FDA
FDA Agrees with Galmed's Plan to use Aramchol Meglumine in the Randomized Double-Blind Placebo-Controlled Part of the Phase 3 ARMOR study
FDA agreed that Galmed can proceed with its proposed clinical studies with Aramchol meglumine in lieu of Aramchol free acid without the need to repeat nonclinical and clinical studies.
FDA Authorizes ImmunityBio Study of Anktiva and PD-L1 t-haNK to Increase Effectiveness of Trodelvy in Triple-Negative Breast Cancer
ImmunityBio today announced it has received FDA authorization to conduct a Phase 1b/2 open-label study to evaluate the safety and preliminary efficacy of its superagonist Anktiva
FDA Accepts Filing of Abbreviated New Drug Application and Grants Priority Review for Nalmefene HCI Injection for the Treatment of Known or Suspected Opioid Overdose
Purdue Pharma L.P. (“Purdue”) announced that FDA has accepted and granted priority review to the company’s Abbreviated New Drug Application for the vial dosage form of nalmefene hydrochloride injection.
FDA Approves EndoClot ® Hemostat to Manage GI Bleeding A Unique Product to Rapidly and Reliably Control Bleeding During GI Procedures
Sedor Pharmaceuticals Receives FDA Approval for SESQUIENT™ (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients
Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S. Food and Drug Administration (FDA) has approved SESQUIENT (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. According to Neurocritical Care Society Guidelines, status epilepticus, which is classified as a single epi
Alzheimer's Drug Discovery Foundation Statement on Today's FDA Independent Panel Vote on Biogen's Aducanumab
An independent FDA advisory committee today signaled in several votes that it does not believe the clinical study data for Biogen's aducanumab supports the drug's approval for patients with early stage Alzheimer's disease.
OliX Pharmaceuticals Announces FDA Clearance of the IND to Evaluate the Efficacy of OLX10010 in Phase 2a Clinical Trial for Hypertrophic Scars
Potential first-in-class treatment for hypertrophic scars with no FDA-approved medicines to to-date Phase 2a trial follows the successful completion of OliX’s Phase 1 trial in the U.K. in November 2019 OliX retains global rights to develop and commercialize OLX10010 outside Asia
The following quote is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response: "The FDA, along with the CDC and our state and local partners, are working to investigate two outbreaks of Shiga toxin-producing E. coli O157:H7 (STEC) illnesses. We do not know what food is causing people to get
miR Scientific announces FDA Breakthrough Device Designation for its Prostate Cancer Liquid Biopsy Test
miR Scientific, LLC , a healthcare company whose purpose is to transform global cancer management by providing early and highly accurate detection, characterization and monitoring of disease, announced today that it has received Breakthrough Device Designation by the U.S Food & Drug Administration for its miR Sentinel™ PCC4 Assay (m
FH Ortho Inc, a well-established innovative orthopedic medical device company, is pleased to announce the FDA clearance of Telegraph Evolution, a next generation humeral nailing system for use in proximal and/or mid-shaft humeral fractures. Chris Valois, General Manager of FH Ortho Inc said, “We are seeing a trend in the US towards humeral fracture nails and away from plating due to advancements in instrumentation and perceived improved patient outc
- Data demonstrates highly reliable test results with 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset - Availability of the new IgM blood test on the ARCHITECT® and Alinity™ platforms is part of Abbott's effort to offer tests across the disease progression of COVID-19 - Abbott's IgM test will give a more complete picture of where patients are in their recovery [12-October-202
The following quote is attributed to Peter Marks , M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research: "Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence a
FDA Clarifies Types of Evidence Relevant to Determining the "Intended Use" of FDA-Regulated Products
Today, we proposed updates to our regulations to clarify the types of evidence the FDA considers when determining the "intended use" of a product. A product's intended use determines whether it is a medical product within the sc
Masimo PVi® Receives FDA Clearance as an Indicator of Fluid Responsiveness on Mechanically Ventilated Patients
Masimo PVi ® Receives FDA Clearance as an Indicator of Fluid Responsiveness on Mechanically Ventilated Patients
Hyperfine Research Receives 510(k) Clearance from US FDA for Market-Ready Swoop™ Portable MRI System
Hyperfine Research, Inc. has received 510(k) clearance from the US FDA for its category-defining portable MRI technology, the Swoop™ Portable MR imaging device. Hyperfine’s Swoop™ system is a point-of-care MR imaging device that wheels directly to the patient’s bedside, plugs into a standard ele
FDA Approves Gadavist ® (gadobutrol) Imaging Bulk Package The first and only gadolinium-based contrast agent with an FDA-approved Imaging Bulk Package presentation for multi-patient dosing with a device (e.g. transfer spike) cleared for use with Gadavist IBP in a room designated for radiological procedures with IV contrast
Foresee Pharmaceuticals Co., Ltd., announced that it has submitted to the U.S. Food and Drug Administration a 505 New Drug Application for Camcevi™ 42mg, a ready-to-use 6-month depot formulation of leuprolide mesylate.
NeoImmuneTech Announces FDA Approval to Proceed with Second Study of NT-I7 (efineptakin alfa) in Adult COVID-19 Patients
NIT’s second trial to evaluate NT-I7’s potential as a COVID-19 therapeutic
New Method Aims to Improve Efficiency of COVID-19 Testing, Optimize Testing Supplies and Increase Overall Capacity
The U.S. Food and Drug Administration continued to take action in the ongoing response to the COVID-19 pandemic:.