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Approvals

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Biocryst Pharmaceuticals’s Intravenous Flu Drug Rapivab
December 22, 2014
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves AbbVie’s All-Oral Hepatitis C Drug Viekira Pak
December 22, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Novartis AG Drug For Rare Hormonal Disorder
December 16, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Amgen Wins FDA Approval For New XGEVA Indication
December 9, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
FDA Grants Breakthrough Therapy Status To Takeda Pharmaceutical Co. Ltd.'s Ixazomib
December 5, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Speedy FDA Approval For Amgen’s Leukemia Immunotherapy BLINCYTO
December 4, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
National Institute for Clinical Excellence (NICE) Reverses October Decision And Approves Roche’s Oncology Drug Gazyvaro
December 2, 2014
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1 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
Drug Development
FDA Requires Additional Data On Bristol-Myers Squibb Company’ Hep C Daclatasvir
November 26, 2014
 · 
1 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
France Strikes Deal For Gilead Sciences, Inc.'s Hep C Drug Sovaldi
November 21, 2014
 · 
1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Purdue Pharma L.P. Wins FDA Approval For Powerful Painkiller Hysingla
November 20, 2014
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2 min read
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PRESS RELEASES
FDA
Evoke Pharma Initiates Commercial Manufacturing of Gimoti™Preparing commercial launch of GIMOTI™ in 4Q 2020
July 15, 2020
 · 
4 min read
FDA
Paragon 28, Inc. is pleased to announce that the U.S. Food and Drug Administration has cleared the APEX 3D™ Total Ankle Replacement System
July 14, 2020
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1 min read
FDA
GSK announces FDA advisory committee votes in favour of positive benefit/risk profile for belantamab mafodotin for patients with relapsed/refractory multiple myeloma
July 14, 2020
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5 min read
FDA
MororphoSys’s Licensee Janssen Announces Approval of Tremfya (Guselkumab) by U.S. FDA for Treatment of Adults with Active Psoriatic Arthritis
July 14, 2020
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6 min read
FDA
Monteris Announces FDA Clearance of NeuroBlate Fusion-S™ Software
July 14, 2020
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3 min read
FDA
Vitls Inc. Announces FDA Clearance of Its Clinical-Grade Platform for Accurate and Continuous Vital Sign Monitoring in the Hospital and Home
July 14, 2020
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2 min read
FDA
FDA Grants the Doraya AHF Catheter Breakthrough Designation
July 14, 2020
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2 min read
FDA
QUBYX Receives FDA 510 (k) Clearance for PerfectLum 4.0 Software & 5K Apple iMac Bundle
July 14, 2020
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3 min read
Drug Development
TREMFYA® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis
July 14, 2020
 · 
15 min read
FDA
Alcon Announces FDA Approval of the OTC Switch of Pataday Once Daily Relief Extra Strength
July 14, 2020
 · 
6 min read
FDA
Pear Therapeutics Announces First Participant Enrolled in Virtual Real-World Study of Adults with Chronic Insomnia
July 13, 2020
 · 
6 min read
FDA
Amneal Launches Generic Fluphenazine Following ANDA Approval by FDA
July 10, 2020
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3 min read
FDA
FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity
July 9, 2020
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13 min read
FDA
Ipsen Announces Updated Indication for Dysport® (abobotulinumtoxinA) for the Treatment of Spasticity in Children
July 9, 2020
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14 min read
FDA
Merck Animal Health Receives U.S. FDA Approval of BRAVECTO® (fluralaner) Monthly Chews
July 9, 2020
 · 
9 min read
FDA
Infervision Receives FDA Clearance for the InferRead Lung CT.AI Product
July 9, 2020
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3 min read
FDA
Baxter Announces U.S. FDA Clearance of Altapore Shape Bioactive Bone Graft for Use in Surgery
July 9, 2020
 · 
6 min read
FDA
Therapixel receives FDA 510(k) clearance for MammoScreen™
July 9, 2020
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2 min read
FDA
Osmotica Pharmaceuticals plc Receives FDA Approval for Upneeq™ (oxymetazoline hydrochloride ophthalmic solution), 0.1% for Acquired Blepharoptosis (Droopy Eyelid) in Adults
July 9, 2020
 · 
7 min read
FDA
Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio® (adalimumab-fkjp)
July 9, 2020
 · 
7 min read
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