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Approvals

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Genzyme Corporation’s Gaucher Disease Pill Cerdelga
August 19, 2014
 · 
2 min read
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FDA
FDA Approves Biogen Idec, Inc. (Massachusetts)'s Multiple Sclerosis Drug Plegridy
August 18, 2014
 · 
8 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Merck & Co. Wins FDA Approval For New Type Of Sleeping Pill
August 13, 2014
 · 
3 min read
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FDA
FDA Green Lights Boehringer Ingelheim Corporation, Eli Lilly and Company’s Jardiance For Type 2 Diabetes
August 1, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Purdue Pharma L.P.’s Hard-to-Abuse Narcotic Painkiller
July 28, 2014
 · 
2 min read
FDA
First Remote-Control Leg Lengthening Implant Cleared by the FDA, Sinai Hospital Reveals
February 8, 2012
 · 
1 min read
FDA
FDA Told To Reconsider Barr Pharmaceuticals, Inc.'s Morning-After Pill Access
March 24, 2009
 · 
1 min read
FDA
CBER: Substantially Equivalent 510(k) Device Information for CaridianBCT, Inc.
October 22, 2008
 · 
1 min read
FDA
FDA Delays: Hurry Up and Wait
September 23, 2008
 · 
1 min read
FDA
Industry Goes on Offense on Medical Device Approvals, AdvaMed
September 5, 2008
 · 
1 min read
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PRESS RELEASES
FDA
Celltex Therapeutics Receives Another FDA Approval: Phase II Clinical Trial Using Mesenchymal Stem Cells (MSCs) as a Prophylactic Against COVID-19
June 26, 2020
 · 
5 min read
FDA
FDA Approves FINTEPLA® (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome
June 25, 2020
 · 
14 min read
FDA
FDA Approves FINTEPLA® (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome
June 25, 2020
 · 
14 min read
FDA
FDA Approves New Therapy for Dravet Syndrome
June 25, 2020
 · 
3 min read
FDA
Bioventus Receives FDA Clearance of Strip Format of its SIGNAFUSE® Bioactive Bone Graft
June 25, 2020
 · 
3 min read
FDA
Babson Diagnostics Receives FDA Emergency Use Authorization for its SARS-CoV-2 IgG Antibody Test
June 25, 2020
 · 
3 min read
FDA
EMD Serono Initiates First Clinical Trial of TLR7 and 8 Inhibitor as a Potential Treatment for Severe Symptoms of Covid-19 Infection
June 25, 2020
 · 
4 min read
FDA
FDA Approves First-Of-Its-Kind Percept™ PC Neurostimulator with BrainSense™ Technology
June 25, 2020
 · 
4 min read
FDA
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that is Not Curable by Surgery or Radiation
June 24, 2020
 · 
34 min read
FDA
Gencurix wins FDA EUA for COVID-19 Test Kit
June 24, 2020
 · 
2 min read
Drug Development
HemoShear Therapeutics Receives FDA Clearance of IND for Phase 2 Study of its Investigational Drug HST5040 for the Treatment of Methylmalonic Acidemia and Propionic Acidemia
June 24, 2020
 · 
3 min read
FDA
Northeast Scientific Inc. Wins 510(k) for IVUS Catheter Reprocessing
June 23, 2020
 · 
1 min read
FDA
Novaremed Announces U.S. FDA Approval of IND Application to Initiate Phase 2 Clinical Study of NRD135S.E1 for the Treatment of Painful Diabetic Peripheral Neuropathy
June 23, 2020
 · 
1 min read
FDA
Companion Medical InPen Receives FDA Clearance for Expanded Pediatric Use
June 23, 2020
 · 
3 min read
FDA
preCARDIA, Inc. Receives FDA Breakthrough Device Designation for Novel, Catheter Based Heart Failure Treatment
June 23, 2020
 · 
2 min read
FDA
OmniPathology Receives FDA Emergency Use Authorization for New Omni-COVID-19 Molecular TestOmniPathology develops its own PCR test with 24-hour turnaround
June 22, 2020
 · 
2 min read
FDA
FDA Accepts Supplemental Biologics License Application (sBLA) for BOTOX® (onabotulinumtoxinA) for the Treatment of Pediatric Patients with Neurogenic Detrusor Overactivity
June 22, 2020
 · 
16 min read
FDA
Conformis Announces 510(k) Clearance for iTotal® Identity PSiTotal® Identity PS joins iTotal® Identity CR as the latest personalized knee technology from Conformis
June 22, 2020
 · 
3 min read
FDA
Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain
June 22, 2020
 · 
10 min read
FDA
FDA Approves Evoke’s GIMOTI™
June 19, 2020
 · 
7 min read
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