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Approvals

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Regeneron, ReGen Therapeutics Plc Eczema Drug Dupilumab Gets FDA Breakthrough Therapy Designation
November 20, 2014
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2 min read
Mylan Inc., Theravance, Inc. Partner Up for $265 Million COPD Pact
FDA
Regeneron’s Eylea Gets Japanese Nod For Macular Edema
November 18, 2014
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1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Genzyme Corporation’s Lemtrada For MS
November 17, 2014
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2 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
FDA
Eli Lilly Wins FDA Approval For Gastric Cancer Combination Drug
November 6, 2014
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2 min read
Deal-Starved Perrigo Company In Talks To Buy $5B Omega Pharma
FDA
FDA Panel Backs Daiichi Sankyo, Inc.'s New A-Fib Drug Savaysa
October 31, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
AstraZeneca PLC Wins FDA Approval For Two-In-One Diabetes Pill
October 30, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
AstraZeneca PLC’s Cancer Drug Pipeline Gets Boost From European Green Light
October 24, 2014
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1 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Vertex Pharmaceuticals (MA) Surges As FDA Advisory Panel Approves Kalydeco’s Label Expansion
October 22, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Panel Unanimously Backs Novartis AG’ Psoriasis Drug
October 20, 2014
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
InterMune, Inc. Wins FDA Approval For Lung Drug At Center Of Roche Deal
October 15, 2014
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2 min read
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PRESS RELEASES
FDA
Nonin Medical Announces FDA Clearance of the CO-Pilot™ Wireless Handheld Multi-Parameter System
July 8, 2020
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2 min read
FDA
FDA Approves Talaris Therapeutics’ IND for Its Allogeneic Cell Therapy FCR001 to Be Evaluated in Patients With a Severe Form of Scleroderma
July 8, 2020
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5 min read
FDA
Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical Announce FDA and Health Canada Approval of INQOVI® (Decitabine and Cedazuridine) Tablets, Oral Hypomethylating Agent (HMA) Therapy for Intermediate and High-Risk MDS and CMML
July 7, 2020
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11 min read
FDA
FDA Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can Be Taken at Home
July 7, 2020
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2 min read
FDA
Getinge Receives 510(k) Clearance for Servo-air® Mechanical Ventilator
July 7, 2020
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2 min read
FDA
Medtronic Gains FDA Clearance, CE Mark for LINQ II™ Insertable Cardiac Monitor (ICM)
July 7, 2020
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4 min read
FDA
FDA Grants Orphan Drug Designation to Neurogene’s Gene Therapy for the Treatment of CLN5 Batten Disease
July 7, 2020
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3 min read
FDA
Senhwa Biosciences’s Silmitasertib Receives Rare Pediatric Disease Designation from U.S. FDA for Treatment of Recurrent Sonic Hedgehog Medulloblastoma
July 7, 2020
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3 min read
FDA
Viveve Announces FDA Approval to Conduct PURSUIT Trial for Improvement of Stress Urinary Incontinence
July 7, 2020
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5 min read
FDA
Dascena Receives FDA Breakthrough Device Designation for Machine Learning Algorithm for Earlier Prediction of Acute Kidney Injury
July 7, 2020
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2 min read
FDA
U.S. FDA Approves Qwo™ (collagenase clostridium histolyticum-aaes), the First Injectable Treatment for Cellulite
July 6, 2020
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8 min read
FDA
Cochlear obtains FDA approval of Kanso 2 Sound Processor, first off-the-ear cochlear implant sound processor with direct smartphone connectivity
July 6, 2020
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7 min read
FDA
Abbott Receives FDA Approval for New Heart Rhythm Devices Featuring Bluetooth Connectivity and Continuous Remote Monitoring
July 6, 2020
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3 min read
Drug Development
ADC Therapeutics Announces U.S. Food and Drug Administration Has Lifted Partial Clinical Hold on Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine
July 6, 2020
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6 min read
FDA
EspeRare Receives FDA Breakthrough Therapy Designation for Investigational Prenatal Treatment ER-004 in X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)
July 6, 2020
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3 min read
FDA
ViiV Healthcare Announces US FDA Approval for Rukobia (fostemsavir), a First-in-Class Treatment for HIV in Adults With Few Treatment Options Available
July 2, 2020
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11 min read
FDA
FDA Approves New HIV Treatment for Patients With Limited Treatment Options
July 2, 2020
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2 min read
FDA
Camargo client Chiasma receives FDA approval for first and only oral somatostatin analog for long-term maintenance treatment of acromegaly
July 2, 2020
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2 min read
FDA
Jaguar Health, Inc. announced today that it has submitted to the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) the final major regulatory filing to support approval of its oral plant-based drug candidate Canalevia™
July 2, 2020
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6 min read
FDA
CENTOGENE Receives FDA Emergency Use Authorization for COVID-19 Molecular Diagnostic Test
July 2, 2020
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5 min read
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