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Approvals

Novartis AG Wins Early Approval for Heart Drug Ernesto, Cuts Death Risk by 20%
FDA
Novartis AG Wins Early Approval for Heart Drug Ernesto, Cuts Death Risk by 20%
July 8, 2015
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5 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Vertex Gets FDA Approval for $259K Per Year CF Drug
July 6, 2015
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3 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
FDA Panel Backs Amgen’s Repatha, But With Strings Attached
June 11, 2015
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4 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Genentech Wins Breakthrough Nod From FDA for Systemic Sclerosis Treatment
June 10, 2015
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4 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
FDA Advisors Back Regeneron, Sanofi’s New Heart Drug With Limits
June 10, 2015
 · 
4 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
FDA Grants Breakthrough Designation to Genzyme’s Experimental ASMD Treatment
June 4, 2015
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2 min read
Gilead’s Hep B Trial Failure Will Inspire M&A Activity, Say Analysts
FDA
Rapamune, Pfizer’s Branding-Troubled Drug, Gets FDA Approval for Rare Lung Disease
May 29, 2015
 · 
3 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
Drug Development
Heart-Stopping Morning Leads to Vertex Rise As FDA News Sees Positives
May 8, 2015
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
AbbVie, Genentech Leukemia Drug Wins Breakthrough Status Tag
May 7, 2015
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Business
AcelRx Crashes as the FDA Rejects Request for Meeting on Pain Drug Device
May 4, 2015
 · 
2 min read
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PRESS RELEASES
FDA
Guardant Health Guardant360® CDx First FDA-Approved Liquid Biopsy for Comprehensive Tumor Mutation Profiling Across All Solid Cancers
August 7, 2020
 · 
7 min read
FDA
PTC Therapeutics Announces FDA Approval of Evrysdi™ (risdiplam) for the Treatment of Spinal Muscular Atrophy in Adults and Children 2 months and older
August 7, 2020
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11 min read
FDA
US FDA Grants Rare Pediatric Disease Designation (RPDD) to Paxalisib for DIPG
August 7, 2020
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5 min read
FDA
U.S. Food and Drug Administration Approves Lampit® (nifurtimox) for the Treatment of Chagas Disease in Children
August 7, 2020
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13 min read
FDA
ViiV Healthcare announces FDA approval of an expanded indication for Dovato (dolutegravir/lamivudine), a complete two-drug regimen for virologically suppressed adults with HIV-1
August 6, 2020
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11 min read
FDA
FDA Approves joimax® Intracs®em Electromagnetic Navigation System for Endoscopic Minimally Invasive Spine Surgery
August 6, 2020
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3 min read
FDA
Adaptive Biotechnologies Receives Expanded FDA Clearance for the clonoSEQ® Assay to Assess Minimal Residual Disease (MRD) in Patients with Chronic Lymphocytic Leukemia
August 6, 2020
 · 
8 min read
Drug Development
Tonix Pharmaceuticals Announces Clearance of IND for TNX-102 SL for Treatment of Alcohol Use Disorder
August 6, 2020
 · 
5 min read
FDA
Seattle Genetics Achieves Milestone Payment Under Antibody-Drug Conjugate Collaboration with GlaxoSmithKline Triggered by BLENREP (belantamab mafodotin-blmf) FDA Approval
August 6, 2020
 · 
4 min read
FDA
FDA Approves Two Emergency INDs for COVID-19 Outpatient TherapyFirst Reported eIND Issued for Outpatient COVID-19 Therapy
August 6, 2020
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4 min read
FDA
FDA Approves GSK’s BLENREP (belantamab mafodotin-blmf) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
August 5, 2020
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16 min read
FDA
FDA Clears SOMATOM On.site from Siemens Healthineers For CT Head Exams at Patient’s Bedside
August 5, 2020
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3 min read
FDA
FDA Formally Accepts PharmaCyte Biotech’s Drug Master File for Company’s Pancreatic Cancer Therapy
August 5, 2020
 · 
4 min read
FDA
Eyenuk Announces FDA Clearance for EyeArt Autonomous AI System for Diabetic Retinopathy Screening
August 5, 2020
 · 
7 min read
FDA
Biotricity Receives FDA clearance for Bioflux Software II SystemThe software significantly improves workflows for analysis, increasing efficiency and reducing costs
August 4, 2020
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4 min read
FDA
Melanoma Research Alliance Hails FDA’s First ‘Triplet’ Combination Approval for Melanoma
August 3, 2020
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3 min read
FDA
Calidi Biotherapeutics Announces FDA Approval for COVID-19 Treatment Manufactured by Partner: Personalized Stem Cells
August 3, 2020
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4 min read
FDA
Stryker’s Neuroform Atlas® Stent System granted an expanded indication, providing a new option for patients with aneurysms in the back of the brain
August 3, 2020
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3 min read
FDA
TYME Announces Orphan Drug Designation for SM-88 as Potential Treatment for Patients with Pancreatic Cancer
August 3, 2020
 · 
7 min read
FDA
Janssen Announces U.S. FDA Approval of SPRAVATO® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior
August 3, 2020
 · 
20 min read
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