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Approvals

FDA
FDA Approves Rockwell Medicall’s Triferic™ For Iron Replacement And Maintenance Of Hemoglobin In Hemodialysis Patient
January 26, 2015
 · 
5 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Says Yes to Rockwell Medical’s Iron Replacement Drug
January 26, 2015
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3 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
FDA
Shire’s $5.2 Billion Bet Pays Off as NPS Pharmaceuticals, Inc.'s Natpara Wins Approval
January 26, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Green Lights Daiichi Sankyo’s New Anti-Clotting Drug
January 9, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Novartis AG Submits Two Lung Drugs for FDA Approval; Analysts Question Decision
January 8, 2015
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Denies Approval for Actavis’ Hypertension Combo Treatment
December 29, 2014
 · 
1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Actavis, Adamas Pharmaceuticals Win FDA Approval for Alzheimer’s Drug Namzaric
December 24, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Novo Nordisk A/S’s Weight Management Drug Saxenda
December 24, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Grants Accelerated Approval for Bristol-Myers Squibb Company’s Skin Cancer Drug Opdivo
December 23, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
AstraZeneca PLC Grabs Accelerated FDA Approval for Lynparza
December 22, 2014
 · 
2 min read
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PRESS RELEASES
FDA
Ultragenyx Announces U.S. Commercial Launch of Dojolvi™ (triheptanoin), the First FDA-Approved Therapy for the Treatment of Long-chain Fatty Acid Oxidation DisordersEstablished UltraCare® Program Provides Ongoing Patient Support Services
July 22, 2020
 · 
7 min read
FDA
Cerapedics Announces FDA approval of an IDE supplement
July 22, 2020
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2 min read
FDA
Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy
July 22, 2020
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16 min read
FDA
BD receives FDA Approval for HPV Test with Extended Genotyping Capabilities
July 22, 2020
 · 
7 min read
FDA
Luminex Files for Emergency Use Authorization for Expanded NxTAG Respiratory Panel Test Including SARS-CoV-2
July 22, 2020
 · 
5 min read
FDA
MC2 Therapeutics Announces U.S. Food and Drug Administration Approval of Wynzora® Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%) for Adults with Plaque Psoriasis
July 22, 2020
 · 
7 min read
FDA
Boston Scientific Receives FDA Approval for Next-Generation WATCHMAN FLX™ Left Atrial Appendage Closure Device
July 21, 2020
 · 
6 min read
FDA
JanOne Receives FDA Authorization for Transfer of Investigational New Drug (IND) Application for its Sodium Nitrite Tablets
July 21, 2020
 · 
4 min read
FDA
FDA Issues EUA for OraRisk® COVID-19 RT-PCR Test from OralDNA® Labs
July 21, 2020
 · 
2 min read
FDA
Paige Receives FDA Clearance for the FullFocus™ Viewer for Digital Pathology
July 21, 2020
 · 
4 min read
Drug Development
FDA clears Abivertinib for Phase 2 safety and efficacy study in hospitalized patients with moderate to severe COVID-19
July 20, 2020
 · 
6 min read
FDA
FX Solutions, SAS. [FX Shoulder, Inc.] Receives FDA 510k Clearances for TiN (Titanium Nitride) Coated Humeral Heads and Glenospheres
July 20, 2020
 · 
1 min read
FDA
KeraNetics announces KeraStat® Cream product cleared by FDA for radiation dermatitis
July 20, 2020
 · 
2 min read
FDA
Ambu Receives FDA Clearance for Its Sterile, Single-Use Duodenoscope
July 17, 2020
 · 
4 min read
FDA
FDA Grants Fast Track Designation For DB102 in Patients with Newly-Diagnosed Glioblastoma (GBM)
July 17, 2020
 · 
3 min read
FDA
Opioid-free Pain Med Orphengesic Forte by Galt Pharmaceuticals Approved by FDA
July 16, 2020
 · 
4 min read
FDA
Kiniksa Announces U.S. Orphan Drug Designation for Rilonacept for the Treatment of Pericarditis
July 16, 2020
 · 
10 min read
Drug Development
NeoImmuneTech Announces Clearance for Investigational New Drug Application of NT-I7 (efineptakin alfa) in Adults with Mild COVID-19
July 15, 2020
 · 
3 min read
FDA
Ascentage Pharma’s Bcl-2 Inhibitor APG-2575 Granted Orphan Drug Designation by the FDA for the Treatment of Waldenström Macroglobulinemia
July 15, 2020
 · 
5 min read
FDA
Edwards’ KONECT RESILIA Aortic Valved Conduit Receives FDA Approval For Complex Aortic Valve Surgeries
July 15, 2020
 · 
4 min read
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