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Approvals

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Bristol-Myers Squibb Grabs Record Fast Approval for Opdivo
March 5, 2015
 · 
3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Sanofi Wins FDA Approval for New Insulin Drug Toujeo
February 26, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Novartis AG’s Farydak Wins FDA Approval After Setback
February 24, 2015
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2 min read
Mylan Inc., Theravance, Inc. Partner Up for $265 Million COPD Pact
FDA
23andMe Wins FDA Approval for First Genetic Test Kit
February 20, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Genentech’s Lucentis Is the First Drug to Win Approval for Diabetic Retinopathy
February 9, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Green Lights Pfizer’s High Profile Breast Cancer Drug Two Months Early
February 3, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
bluebird bio’s Rare Blood Disorder Drug Tagged a Breakthrough by the FDA
February 2, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Intercept Pharmaceuticals Rockets as Lead NASH Drug Snags Breakthrough Status From the FDA
January 30, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Green Lights Bristol-Myers Squibb Company, Johnson & Johnson HIV Pills
January 30, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Backs Teva Pharmaceutical Industries Limited’s Generic Nexium in Blow to AstraZeneca PLC, Ranbaxy Laboratories
January 27, 2015
 · 
2 min read
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PRESS RELEASES
FDA
Momenta Pharmaceuticals Announces FDA Rare Pediatric Disease Designation for Nipocalimab in HDFN
July 28, 2020
 · 
7 min read
FDA
Protara Therapeutics Receives Rare Pediatric Disease Designation for TARA-002 for the Treatment of Lymphatic Malformations
July 28, 2020
 · 
3 min read
FDA
Color Receives Emergency Use Authorization for Unmonitored COVID-19 Testing Technology
July 27, 2020
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4 min read
FDA
Generex Biotechnology Announces That FDA has Accepted the Pre-IND Briefing Package for the Company’s Ii-Key-SARS-CoV-2 Vaccine and Will Provide a Written Response by August 24, 2020
July 27, 2020
 · 
4 min read
FDA
Zebra Medical Vision Secures its First FDA Clearance in Oncology, Boosting Early Detection of Breast Cancer in Mammograms
July 27, 2020
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5 min read
FDA
Merus announces FDA Orphan Drug Designation of Zenocutuzumab for the Treatment of Pancreatic Cancer
July 27, 2020
 · 
6 min read
FDA
Ocugen Granted FDA Orphan Drug Designation for OCU400 (AAV-hNR2E3) Gene Therapy for the Treatment of RHO Mutation-Associated Retinal Degenerative Disease
July 27, 2020
 · 
5 min read
FDA
NeoImmuneTech Announces Receipt of IND Clearance to Conduct Window-of-Opportunity Trial of NT-I7 (efineptakin alfa) in Patients with Locally Recurrent Squamous Cell Carcinoma of Head and Neck
July 27, 2020
 · 
3 min read
Drug Development
Can-Fite Submits Investigational New Drug Application to U.S. FDA for COVID-19 Phase II Study
July 27, 2020
 · 
6 min read
FDA
Checkmate Pharmaceuticals Granted FDA Fast Track Designation for CMP-001 Combined with PD-1 Blockade in the Treatment of Certain Types of Metastatic or Unresectable Melanoma
July 27, 2020
 · 
3 min read
FDA
Stratus™ Medical announces FDA 510k clearance for the Vesta™ RF Cannula to expand product portfolio and the first Vesta patient treatments in the United States
July 27, 2020
 · 
2 min read
FDA
CARISMA Therapeutics Announces FDA Clearance of IND Application for First-Ever Engineered Macrophage Immunotherapy
July 27, 2020
 · 
4 min read
FDA
LabCorp Receives Authorization for COVID-19 Sample Pooling
July 25, 2020
 · 
6 min read
FDA
U.S. FDA Approves Kite’s Tecartus™, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma
July 24, 2020
 · 
15 min read
FDA
Sarepta Therapeutics Receives Fast Track Designation for SRP-9001 Micro-Dystrophin Gene Therapy for the Treatment of Duchenne Muscular Dystrophy
July 24, 2020
 · 
5 min read
FDA
Palliare Receives US FDA 510k Clearance for EVA15 Insufflator and Smoke Evacuation System
July 23, 2020
 · 
3 min read
FDA
Vita Therapeutics receives Orphan Drug Designation from FDA for new novel treatment
July 23, 2020
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2 min read
FDA
Abbott Receives FDA Approval for iOS-Compatible App Allowing People Living With Chronic Pain and Movement Disorders to Personalize Therapy Via Their Mobile Device
July 23, 2020
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4 min read
FDA
FDA Clears First Blood Test for Identifying a Novel Allergic Sensitization to Red Meat
July 23, 2020
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3 min read
FDA
Caption Health Receives FDA 510(k) Clearance for Innovation in Point-of-Care Ejection Fraction Evaluation
July 23, 2020
 · 
4 min read
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