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Approvals

Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Actelion’s Uptravi Received FDA Approval, to Enter U.S. Market in January
December 22, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Investors Elated as Amgen Wins FDA Approval for First-of-Its-Kind Cancer Killing Virus Drug
October 28, 2015
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3 min read
Drug Development
FDA Designates Pfizer’s Acute Lymphoblastic Leukemia Drug Breakthrough Status
October 19, 2015
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7 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
As Spinoff Rumors Spin, Sanofi’s Cholesterol Drug Praluent Gets Approval in Europe
September 28, 2015
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3 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
Drug Development
Genentech’s Hemophilia A Drug Gets Breakthrough Designation in Potential $11 Billion Market
September 4, 2015
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2 min read
FDA Approval of Amgen’s Cholesterol Drug Repatha Could Boost Job Growth on East Coast
FDA
FDA Approval of Amgen’s Cholesterol Drug Repatha Could Boost Job Growth on East Coast
August 28, 2015
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2 min read
Biowarfare Company Emergent's Cancer Spinoff Aptevo Therapeutics to Employ 70 - 90 in Seattle
FDA
Sprout to Expand to 200 Employees After FDA Approval of Female Sex-Drive Drug
August 19, 2015
 · 
2 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
Sprout’s First-Ever Female Libido Drug Comes With Boxed Warning and Controversy
August 19, 2015
 · 
4 min read
Biogen Idec Alzheimer's Drug Aducanumab Exceeds Expectations
FDA
FDA Green Lights First 3D Printed Drug From Aprecia
August 3, 2015
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2 min read
Astellas Pharma, Proteostasis Therapeutics Forge $1.2 Billion Genetic Disease Drug Development Pact
FDA
Amgen Beats Sanofi/Regeneron to European Market for Cholesterol Drug, but Race is Still on for U.S. Market
July 21, 2015
 · 
3 min read
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PRESS RELEASES
FDA
RapidAI Receives FDA Clearance of Rapid LVO For Identification of Suspected Large Vessel Occlusions
August 13, 2020
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2 min read
Drug Development
Enzychem Lifesciences Announces FDA Acceptance of Phase 2 Study of EC-18 in Preventing Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 Pneumonia
August 13, 2020
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3 min read
FDA
ANTI-PD-1/CTLA-4 Bi-specific Antibody (AK104) of Akeso Granted FDA Fast Track Designation for Recurrent and Metastatic Cervical Cancer
August 13, 2020
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3 min read
FDA
Scholar Rock Announces that SRK-015 has Received Rare Pediatric Disease Designation from U.S. FDA for the Treatment of Spinal Muscular Atrophy
August 13, 2020
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6 min read
FDA
FDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation
August 12, 2020
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4 min read
FDA
Baxter Obtains U.S. FDA Emergency Use Authorizations for HF20 Set and ST Set Used in CRRT During Covid-19 Pandemic
August 12, 2020
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7 min read
FDA
Lantheus Holdings, Inc. Announces FDA Approval of VIALMIX® RFID Device for DEFINITY®
August 12, 2020
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6 min read
Drug Development
FDA Approves Initiation of IGC’s Cannabinoid Trial on Alzheimer’s Patients
August 11, 2020
 · 
4 min read
FDA
Life Spine Announces FDA 510(k) Clearance for the PLATEAU®-X Ti Lateral Lumbar Spacer System
August 11, 2020
 · 
1 min read
Drug Development
FDA Approves American Gene Technologies (AGT) to Move Forward with Phase 1 Clinical Trial of HIV Cure Program
August 11, 2020
 · 
6 min read
FDA
RenovaCare Receives FDA Conditional IDE Approval of CellMist™ System and SkinGun™ Device, Enabling Clinical Study for Safety and Feasibility
August 11, 2020
 · 
7 min read
FDA
Helix Receives FDA Emergency Use Authorization for the HelixⓇ COVID-19 NGS Test, One of the First Sequencing-Based COVID-19 Tests
August 10, 2020
 · 
3 min read
FDA
US FDA Approves Spectral Medical’s Protocol Amendment for TIGRIS
August 10, 2020
 · 
3 min read
FDA
Aquestive Therapeutics Receives FDA Fast Track Designation for AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Treatment of Allergic Reactions Including Anaphylaxis
August 10, 2020
 · 
9 min read
FDA
FDA Clears Appili Therapeutics to Expand its Phase 2 Clinical Trial of Favipiravir for the Potential Prevention of COVID-19 at U.S. Long-Term Care Facilities
August 10, 2020
 · 
7 min read
FDA
Trevena Announces FDA Approval of OLINVYK™ (oliceridine) injection
August 10, 2020
 · 
17 min read
FDA
FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings
August 7, 2020
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2 min read
FDA
ADDING MULTIMEDIA FDA Approves Genentech’s Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older
August 7, 2020
 · 
12 min read
FDA
FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test
August 7, 2020
 · 
3 min read
FDA
FDA Approves Oral Treatment for Spinal Muscular Atrophy
August 7, 2020
 · 
3 min read
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