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Policy
Biopharma Update on the Novel Coronavirus: September 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 21, 2020.
September 21, 2020
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2 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 18
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 18, 2020.
September 17, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 16
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 16, 2020.
September 16, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 14
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 14, 2020.
September 14, 2020
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3 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: September 11
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 11, 2020.
September 10, 2020
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2 min read
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BioSpace Editorial Staff
Treatment of asthma coming very soon.
FDA
GSK’s Trelegy Ellipta Wins Approval as Treatment of Asthma
GlaxoSmithKline’s Trelegy Ellipta won regulatory approval for the treatment of asthma in patients aged 18 years and older. Here’s what you need to learn.
September 10, 2020
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2 min read
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Alex Keown
Policy
Biopharma Update on the Novel Coronavirus: September 9
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 9, 2020.
September 8, 2020
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4 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: September 4
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 4, 2020.
September 3, 2020
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3 min read
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BioSpace Editorial Staff
FDA
FDA Approves New HIV-1/HIV-2 Qualitative Test from Roche
This test will give healthcare providers a single result to confirm an HIV diagnosis with patients and differentiate between HIV-1 and HIV-2.
September 2, 2020
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2 min read
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Krystle Vermes
Drug Development
At Least 4 Vaccine Candidates Backed by U.S. Government Predicted to Fail, Analytics Group Says
The U.S. government has financially backed the development of six different vaccine candidates aimed at the novel coronavirus. Although billions of dollars have been appropriated to the pandemic, at least four of those potential preventative treatments are predicted to fail in the clinic.
September 2, 2020
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3 min read
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Alex Keown
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PRESS RELEASES
FDA
MDA Celebrates the Approval of MTPA’s RADICAVA ORS to Treat ALS
May 13, 2022
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4 min read
FDA
FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes
May 13, 2022
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4 min read
FDA
Mitsubishi Tanabe Pharma America Announces FDA Approval of RADICAVA ORS® (edaravone) for the Treatment of ALS
May 13, 2022
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11 min read
FDA
PolarityTE Announces FDA Regenerative Medicine Advanced Therapy Designation Granted to SkinTE®
May 13, 2022
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3 min read
FDA
Medtronic receives FDA approval for latest generation drug-eluting coronary stent system
May 13, 2022
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4 min read
FDA
Accelus Receives U.S. FDA 510(k) Clearance for its FlareHawk TiHawk11 Interbody Fusion System
May 12, 2022
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2 min read
FDA
FDA Grants Breakthrough Device Designation to Remedee Labs for its groundbreaking endorphin stimulation solution for the management of Fibromyalgia
May 12, 2022
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3 min read
FDA
Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for Treatment of Duchenne Muscular Dystrophy
May 12, 2022
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6 min read
FDA
Hologic Announces FDA Approval of Aptima® CMV Quant Assay for Human Cytomegalovirus
May 10, 2022
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4 min read
Drug Development
Elpiscience Announces FDA IND Clearance of ES014, a First-in-Class Anti-CD39xTGF-β Bispecific Antibody for Patients with Advanced Solid Tumors
May 9, 2022
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2 min read
Drug Development
Acer Therapeutics Announces Agreement with FDA on Special Protocol Assessment for its Phase 3 EDSIVO™ (celiprolol) Trial in Vascular Ehlers-Danlos Syndrome PatientsPhase 3 DiSCOVER clinical trial initiation expected by end of Q2 2022
May 9, 2022
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8 min read
FDA
CVRx® Receives MR-Conditional Labeling Approval for its Barostim™ Heart Failure System
May 9, 2022
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2 min read
Drug Development
Resverlogix Announces Type C Meeting with FDA for CORAL, a Phase 3 High-risk COVID-19 Outpatient Study
May 9, 2022
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7 min read
FDA
Fujirebio Diagnostics Lumipulse® G β-Amyloid Ratio (1-42/1-40) In Vitro Diagnostic Test Receives Marketing Authorization for the Assessment of Alzheimer’s Disease
May 5, 2022
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5 min read
FDA
FDA Approves Orphalan’s CUVRIOR™ (trientine tetrahydrochloride), the first treatment for Wilson’s disease in over five decades
May 4, 2022
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1 min read
Drug Development
Ilya Pharma announces FDA clearance of IND for first-in-class ILP100-Topical immunotherapy treatment of surgical wounds in patients with prediabetes, diabetes and obesity
May 4, 2022
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2 min read
FDA
FDA Grants PMA for the AccelStim Bone Growth Stimulation Device — Expanding Orthofix’s Portfolio of Market-Leading Bone Healing Therapy Solutions
May 4, 2022
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5 min read
FDA
Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA™ TRIPLE PAK™ (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA™ DUAL PAK™ (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults
May 3, 2022
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13 min read
FDA
FDA Clears iSono Health’s ATUSA™, the World’s First Automated and Wearable 3D Breast Ultrasound
May 3, 2022
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3 min read
FDA
Graphite Bio Announces U.S. FDA Fast Track Designation Granted to GPH101 for the Treatment of Sickle Cell Disease
May 3, 2022
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5 min read
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