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FDA
451 Articles Available
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FDA
FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
PR-M06-20-NI-041
COVID-19
Regulating Clinical Trials in Pandemic Times
PAP-Q2-20-NI-005
COVID-19 Testing
The FDA Confirms Certain COVID-19 Serology and Antibody Tests Should Not Be Used
PR-M06-20-NI-035
FDA Approval
FDA Approves First-Of-Its-Kind Percep PC Neurostimulator with BrainSense Technology
PR-M06-20-NI-037
Predictive Analytics
CLEW Receives FDA Emergency Use Authorization for Its Predictive Analytics Platform in Support of COVID-19 Patients
PR-M06-20-NI-038
Clinical Trials
FDA Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials
PR-M06-20-NI-032
FDA Approval
FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD
PR-M06-20-NI-021
COVID-19
FDA Clears IND for iNKT Cells to Treat COVID-19 Patients
PR-M06-20-NI-012
FDA Accepts Shionogi’s Supplemental New Drug Application for the Treatment of Ventilator-Associated Bacterial Pneumonia
PR-M06-20-NI-013
FDA Alert
FDA Alerts Patients of Amneal and Impax Laboratories Epinephrine Auto-Injector Device Malfunctions
PR-M06-20-NI-015
FDA
FDA Reissues Emergency Use Authorizations Revising Which Types of Respirators Can Be Decontaminated for Reuse
PR-M06-20-NI-011
Emergency Use Authorization
FDA Issues Emergency Use Authorization for Impella RP as Therapy for COVID-19 Patients with Right Heart Failure
PR-M06-20-NI-002
FDA Antibody Tests
FDA Provides Promised Transparency for Antibody Tests
COVID-19 Test
FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests
PR-M05-20-NI-026
FDA Authorization
Abbot Receives FDA Authorization for COVID-19 Antibody Blood Test System
PR-M05-20-NI-023
Antigen Test
FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients
PR-M05-20-NI-022
COVID-19
Trxade Group, Inc. Withdraws Its Previously Filed FDA Emergency Use Authorization for Rapid COVID-19 Testing Kit
PR-M05-20-NI-018
FDA
FDA Accepts for Priority Review Bristol Myers Squibb’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloid Leukemia
PR-M05-20-NI-012
FDA Approval
FDA Approves New Meningococcal Vaccination
PR-M04-20-NI-041
COVID-19 At-Home Testing
FDA Authorizes First Test for Patient At-Home Sample Collection
PR-M04-20-NI-037
FDA Approval
Roche Receives FDA Approval for Cobas HPV Test to Identify Women at Risk for Cervical Cancer
PR-M04-20-NI-031
FDA Statement
FDA Statement on Oral Fluid Test for COVID-19
PR-M04-20-NI-027
Priority Review
FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola
PR-M04-20-NI-025
COVID-19
COVID-19: A Look at the Virus, its Epidemiology, Therapeutic and Vaccine Development Efforts and Impacts of the Pandemic
PAO-Q2-20-NI-001
1
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