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Approvals

FDA
Cannabis Drug On Sale In Canada
October 19, 2005
 · 
1 min read
FDA
Anthrax Test, Developed By Army And CDC, Receives FDA Approval
October 19, 2005
 · 
1 min read
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PRESS RELEASES
FDA
Rhythm Pharmaceuticals Announces FDA Acceptance of New Drug Application for Setmelanotide for the Treatment of POMC and LEPR Deficiency Obesities
May 13, 2020
 · 
6 min read
FDA
Arbor Pharmaceuticals Announces FDA Filing Acceptance of New Drug Application (NDA) for AR19, an Investigational ADHD Prescription Stimulant Treatment Specifically Designed to Resist Physical Manipulation for Nonmedical Misuse or Abuse
May 13, 2020
 · 
4 min read
FDA
FDA Issues Emergency Use Authorization for Eko’s ECG-based Low Ejection Fraction Screening Algorithm, Designed to Improve Detection of Heart Failure During COVID-19 Pandemic
May 13, 2020
 · 
5 min read
FDA
CardioFocus Announces US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation
May 12, 2020
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4 min read
FDA
FDA permits use of icometrix’s AI-based quantification for chest CT in COVID-19
May 12, 2020
 · 
2 min read
FDA
Abbott Receives FDA Emergency Use Authorization for COVID-19 Molecular Test on New Alinity™ m System
May 12, 2020
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3 min read
FDA
Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
May 12, 2020
 · 
8 min read
FDA
FDA Clears New XO Cross Microcatheter Platform
May 12, 2020
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2 min read
FDA
FDA Expedites Clearance of Caption Health Ultrasound Software to Aid Frontline Healthcare Workers in Fight Against COVID-19 Pandemic
May 12, 2020
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5 min read
FDA
FDA Approves Aspenstate’s AiRTouch Portable X-Ray System for Human Medical Use
May 11, 2020
 · 
2 min read
FDA
Abbott Receives FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity™ i System
May 11, 2020
 · 
3 min read
FDA
LYNPARZA (Olaparib) Approved in US as 1st-line Maintenance Treatment With bevacizumab For HRD-Positive Advanced Ovarian Cancer
May 11, 2020
 · 
18 min read
FDA
Myriad Receives FDA Approval of myChoice CDx® as Companion Diagnostic for Lynparza™ (olaparib) In Patients with Advanced Ovarian Cancer
May 11, 2020
 · 
7 min read
FDA
Rutgers Clinical Genomics Laboratory Receives FDA Approval to Add Direct-to-Patient at-Home Self-Collection Saliva Kits for COVID-19 Testing Exclusively Using Spectrum Solutions™ Saliva Collection Device
May 11, 2020
 · 
4 min read
FDA
Lilly Receives U.S. FDA Approval for Retevmo™ (selpercatinib), the First Therapy Specifically for Patients with Advanced RET-Driven Lung and Thyroid Cancers
May 8, 2020
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18 min read
FDA
FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion
May 8, 2020
 · 
6 min read
FDA
FDA Permits Use of Aidoc’s AI Algorithms to Detect and Prioritize Incidental CT Findings Associated With COVID-19
May 8, 2020
 · 
2 min read
FDA
FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure
May 8, 2020
 · 
18 min read
Business
FDA Grants Fast Track Designation for Omecamtiv Mecarbil in Heart FailureFast Track Designation Highlights the Urgent Need for New Heart Failure Treatment Options
May 8, 2020
 · 
18 min read
FDA
RedHill Biopharma Receives FDA Approval for COVID-19 Clinical Study with Opaganib in the U.S.
May 8, 2020
 · 
11 min read
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