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261,715 Results for "3dbio therapeutics".
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Drug Development
3DBio Therapeutics and the Microtia-Congenital Ear Deformity Institute Conduct Human Ear Reconstruction Using 3D-Bioprinted Living Tissue Implant in a First-in-Human Clinical Trial
3DBio Therapeutics, a clinical-stage regenerative medicine company, and the Microtia-Congenital Ear Deformity Institute announced they have conducted a human ear reconstruction using the AuriNovo™ implant, an investigational, patient-matched, 3D-bioprinted living tissue ear implant.
June 2, 2022
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8 min read
Business
3DBio Therapeutics, Inc. Strengthens Board of Directors, Welcomes Scott Dylla, Ph.D.
3DBio Therapeutics, an emerging leader in the field of 3D-bioprinting for human therapeutic use, today announced Scott Dylla, Ph.D has joined its Board of Directors.
October 30, 2020
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2 min read
Drug Development
Our Mission at Voyager Therapeutics: Define the Future of Neurogenetic Medicines
We are in an unprecedented time in neurotherapeutics. Medicines that address the causative disease biology underlying central nervous system
May 8, 2024
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2 min read
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Voyager Therapeutics, Inc.
Pharm Country
3DBio Therapeutics Receives Orphan Drug Designation for AuriNovo™ for Ear Reconstruction in Microtia Patients
3DBio Therapeutics, an emerging leader in the field of 3D-bioprinting for human therapeutic use, today announced it has received Orphan Drug Designation for AuriNovo™, an investigational combination product for reconstruction of the outer ear in patients with microtia
November 19, 2019
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2 min read
Regulatory
FDA Warns Applied Therapeutics of ‘Objectionable Conditions’ in Govorestat Study
The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.
December 4, 2024
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2 min read
·
Tristan Manalac
Press Releases
NeuroEM Therapeutics(R) Accepted into StartUp Health’s Alzheimer’s Moonshot Community(TM)
September 19, 2024
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4 min read
Pharm Country
3DBio Therapeutics Receives FDA Rare Pediatric Disease Designation for AuriNovo™ for Ear Reconstruction in Microtia Patients
3DBio Therapeutics, an emerging leader in the field of 3D-bioprinting for human therapeutic use, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation for AuriNovo™, an investigational combination product for reconstruction of the outer ear in patients with microtia.
December 6, 2019
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3 min read
Press Releases
Cara Therapeutics and Tvardi Therapeutics Announce Entry into Merger Agreement
December 18, 2024
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16 min read
Complete response letters
Applied Therapeutics Crashes After FDA Rejection of Rare Disease Drug
After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.
December 2, 2024
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3 min read
·
Tristan Manalac
Layoffs
Spero Therapeutics to Lay Off 39% of Employees
Following disappointing results for an antibiotic candidate whose development program is now being suspended, Spero Therapeutics is looking to extend its cash runway while it focuses on other assets in its pipeline.
October 30, 2024
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1 min read
·
Angela Gabriel
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