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Approvals

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves Biogen and AbbVie’s Once-Monthly MS Drug Zinbryta
May 31, 2016
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2 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
Titan Pharma Receives FDA Approval for the First Ever Implantable Device for Opioid Dependency
May 27, 2016
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3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Genentech Nabs FDA Approval of First New Bladder Cancer Drug in 30 Years
May 18, 2016
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3 min read
FDA
Chiasma Chief Says Firm May Challenge FDA Over Rare-Disease Drug Rejection
May 12, 2016
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2 min read
FDA
Betting Intensifies Over Sarepta’s DMD Drug
May 6, 2016
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1 min read
Here’s Why 5 Billionaire-Led Funds Gobbled Up 3.3 Million Shares of Celldex Stock
FDA
Sarepta Craters as the FDA Releases Documents Ahead of Monday’s DMD Drug Hearing
April 21, 2016
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3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
36 DMD Experts Send Letter to the FDA Urging Approval of Sarepta’s Drug
March 22, 2016
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4 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Roche’s Multiple Sclerosis Drug Gets Breakthrough Status, Likely to Haunt Biogen
February 17, 2016
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2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
AstraZeneca PLC Continues Its Immuno-Oncology Roll, Durvalumab Gets Breathrough Designation for Bladder Cancer
February 17, 2016
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Approves AVANIR New Migraine Treatment With Unique Inhalant Delivery System
January 29, 2016
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2 min read
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PRESS RELEASES
FDA
Pelvital Announces FDA Clearance of Flyte™, In-Home Pelvic Floor Muscle Treatment for Stress Urinary Incontinence
August 20, 2020
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3 min read
FDA
Kubota Vision Receives Orphan Products Clinical Trials Grants to Emixustat for Stargardt Disease
August 20, 2020
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6 min read
FDA
US FDA Awards Fast Track Designation (FTD) to Paxalisib for Glioblastoma
August 20, 2020
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4 min read
FDA
Romark Announces FDA Approval Of New Manufacturing Facility In Manati, Puerto Rico
August 20, 2020
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2 min read
FDA
Medtronic Begins Post-Market, Real-World Study of the InterStim™ Micro System
August 20, 2020
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3 min read
FDA
U.S. FDA grants rare pediatric disease designation to AmideBio’s glucagon analog for the treatment of congenital hyperinsulinism
August 20, 2020
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2 min read
FDA
New treatment solution for U.S. cervical cancer patients now available for clinical use
August 19, 2020
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3 min read
FDA
Accelerate Diagnostics Announces FDA Emergency Use Authorization for COVID-19 Antibody Testing System
August 18, 2020
 · 
5 min read
FDA
23andMe Granted New FDA Clearance to Provide Interpretive Drug Information for Two Commonly Prescribed Medications
August 18, 2020
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4 min read
FDA
ClearMask receives FDA clearance for world’s first fully transparent surgical mask
August 18, 2020
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3 min read
FDA
FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord
August 17, 2020
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3 min read
FDA
Endospan Receives FDA IDE Approval to Initiate a Pivotal Study of the NEXUS™ Aortic Arch Stent Graft System
August 17, 2020
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3 min read
FDA
Mustang Bio Announces Rare Pediatric Disease Designation for MB-107 for the Treatment of X-linked Severe Combined Immunodeficiency
August 17, 2020
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6 min read
FDA
Immunomedics Announces FDA Approval of Samsung Biologics as Antibody Manufacturer for Trodelvy™Approval enhances long-term supply of Trodelvy
August 17, 2020
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5 min read
FDA
Emergent BioSolutions Announces FDA Approval of NARCAN® (naloxone HCl) Nasal Spray Shelf Life Extension to 36 Months
August 17, 2020
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5 min read
FDA
ADDING MULTIMEDIA FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder
August 15, 2020
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14 min read
Drug Development
Lupin Presents Phase 3 Data for Solosec® (secnidazole) Demonstrating Significant Response Rate in Female Patients with Trichomoniasis
August 14, 2020
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9 min read
FDA
Masimo PVi® Receives FDA Clearance as an Indicator of Fluid Responsiveness on Mechanically Ventilated Patients
August 14, 2020
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11 min read
FDA
FDA Approves Gadavist® (gadobutrol) Imaging Bulk Package
August 13, 2020
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8 min read
FDA
Hyperfine Research Receives 510(k) Clearance from US FDA for Market-Ready Swoop™ Portable MRI System
August 13, 2020
 · 
3 min read
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