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Approvals

What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Clovis Oncology Stock Jumps as FDA Skips Review Panel for New Cancer Drug
September 9, 2016
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2 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
Another Celgene Bet Pays Off as Agios Eyes Early Approval of Leukemia Drug
September 7, 2016
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2 min read
Why This Tiny Biotech is Giving Cash to Amgen Researchers
FDA
Amgen Remains Hush-Hush Over FDA Rejection of Parsabiv
August 25, 2016
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Bay Area’s Portola Plummets as FDA Rejects AndexXa NDA
August 18, 2016
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3 min read
With Hopes of Bolstering Sanofi’s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S.
FDA
With Hopes of Bolstering Sanofi’s Sagging Diabetes Sector, Announces FDA Approval of Adlyxin in U.S.
July 28, 2016
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3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Amid Trial Concerns, FDA Delays Approval Decision for Merck & Co.'s C. Diff Drug, New PDUFA Date Set
July 22, 2016
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2 min read
What You Missed: Nippon Fine Chemical Formed Human Barricade to Stop FDA Employee
FDA
Opko Health Rockets on FDA Approval of Rayaldee Four Months Ahead of PDUFA Date
June 21, 2016
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Shire Nabs Breakthrough Tags for Drug to Treat Rare Gastrointestinal Conditions
June 13, 2016
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3 min read
For Sale: Pfizer's $3.4 Billion Consumer Healthcare Business
FDA
Pfizer Quietly Raised Drug Prices By an Average of 8.8% Last Week
June 10, 2016
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Questions Merck & Co.'s C. Diff Diarrhea Medication’s Efficacy
June 8, 2016
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2 min read
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PRESS RELEASES
FDA
Synchron’s Stentrode Brain-Computer Interface Receives Breakthrough Device Designation from FDA
August 27, 2020
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5 min read
FDA
Healeon Announces FDA 510(k) Clearance for Duet Office-Based Blood Separation and Concentration System
August 27, 2020
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3 min read
FDA
B. Braun Receives FDA Clearance for SpaceStation MRI: Allows Space® Infusion Pumps to Continuously Deliver Medications Within the MRI Suite
August 27, 2020
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4 min read
FDA
Cassiopea Receives FDA Approval for Winlevi® (clascoterone cream 1%), First-in-Class Topical Acne Treatment Targeting the Androgen Receptor
August 27, 2020
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5 min read
FDA
FDA Approves FoundationOne® Liquid CDx to Serve as Rubraca® (rucaparib) Companion Diagnostic to Identify Eligible Patients with BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate Cancer (mCRPC)
August 26, 2020
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11 min read
FDA
FDA Approves Foundation Medicine’s FoundationOne®Liquid CDx, a Comprehensive Pan-Tumor Liquid Biopsy Test with Multiple Companion Diagnostic Indications for Patients with Advanced Cancer
August 26, 2020
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8 min read
FDA
Alcami Providing Commercial Manufacturing for Trevena’s Recently FDA Approved OLINVYK™
August 26, 2020
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1 min read
FDA
FDA Approves MED-EL’s RONDO 3 All-in-One Audio Processor
August 26, 2020
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4 min read
FDA
SurGenTec® Announces FDA Clearance for OsteoFlo® NanoPutty® (Quadphasic Synthetic Bone Graft)
August 26, 2020
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3 min read
FDA
PTC Therapeutics Announces First Commercial Milestone Payment Following U.S. FDA Approval of Evrysdi™ (risdiplam)
August 26, 2020
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4 min read
FDA
U.S. FDA Approves CYSTADROPS® (Cysteamine Ophthalmic Solution) 0.37%, A New Practical Treatment Option for the Ocular Manifestations of Cystinosis
August 25, 2020
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6 min read
FDA
Metacrine Announces MET409 Receives FDA Fast Track Designation for the Treatment of NASH
August 25, 2020
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2 min read
FDA
Ligand Announces Amgen’s KYPROLIS® Approved by FDA as Combination Regimen with DARZALEX® and Dexamethasone in Once- and Twice-Weekly Dosing Regimens for Patients with Relapsed/Refractory Multiple Myeloma
August 24, 2020
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18 min read
FDA
Turning Point Therapeutics Granted Fast-Track Designation for Repotrectinib in NTRK-Positive TKI-Pretreated Advanced Solid Tumors
August 24, 2020
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5 min read
FDA
Editas Medicine Receives Rare Pediatric Disease Designation for EDIT-301 for the Treatment of Sickle Cell Disease
August 24, 2020
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4 min read
FDA
XBiotech-Developed COVID-19 Test Supports Convalescent Blood Treatments Now Approved Under FDA Emergency Use Authorization
August 24, 2020
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6 min read
FDA
Medtronic Evolut TAVR System Receives Updated U.S. Labeling Revising Precaution for Treatment of Low-Risk Patients with Bicuspid Aortic Stenosis
August 21, 2020
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3 min read
FDA
U.S. FDA Approves New DARZALEX® (daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma
August 20, 2020
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18 min read
FDA
FDA Approves New KYPROLIS® (carfilzomib) Combination Regimen With DARZALEX® (daratumumab) And Dexamethasone In Both Once- And Twice-Weekly Dosing Regimens
August 20, 2020
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21 min read
FDA
FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
August 20, 2020
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20 min read
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