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FDA Approval
FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival
PR-M04-21-007
FDA Approval
United Therapeutics Announces FDA Approval and Launch of Tyvaso for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
PR-M04-21-003
FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer
PR-M11-20-028
FDA Authorization
Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19
PR-M11-20-022
Fast Track
Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer
PR-M11-20-012
Decentralized Trials
Protecting Clinical Research and Patients Through Decentralized Trial Strategies
PAP-Q3-20-CL-025
Oral COVID-19 Vaccine
Vaxart Announces FDA Clearance of IND Application for Oral COVID-19 Vaccine
PR-M09-20-NI-19
FDA Approval
FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients
PR-M09-20-NI-04
COVID-19
Gilead’s Remdesivir Receives FDA Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19
PR-M08-20-NI-48
FDA Approval
Cassiopea Receives FDA Approval for Acne Drug
PR-M08-20-NI-44
FDA
FDA Accepts Application for Xolair Prefilled Syringe for Self-Administration Across All Indications
PR-M08-20-NI-32
Diagnostic Testing
FDA Issues Emergency Use Authorization to Yale School of Public Health for SalivaDirect COVID-19 Test
PR-M08-20-NI-27
Liquid Biopsy
FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test
PR-M08-20-NI-17
FDA Approval
FDA Approves GSK’s BLENREP for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
PR-M08-20-NI-11
COVID-19 Treatment
Common FDA-Approved Drug May Effectively Neutralize Virus That Causes COVID-19
PR-M07-20-NI-32
COVID-19 Testing
FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing
PR-M07-20-NI-29
FDA
FDA Prepares for Resumption of Domestic Inspections with New Risk Assessment System
PR-M07-20-NI-016
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
Predictive Analytics
CLEW Receives FDA Emergency Use Authorization for Its Predictive Analytics Platform in Support of COVID-19 Patients
PR-M06-20-NI-038
FDA Approval
FDA Approves First-Of-Its-Kind Percep PC Neurostimulator with BrainSense Technology
PR-M06-20-NI-037
COVID-19 Testing
The FDA Confirms Certain COVID-19 Serology and Antibody Tests Should Not Be Used
PR-M06-20-NI-035
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
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