pediatric product News
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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. Microtia is a rare congenital disorder causing the outer ear ...
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Blue Chip Medical Appoints Dorian Drake International as its Export Representative for Latin America and the Caribbean
Blue Chip Medical Products, Inc., a manufacturer of U.S.-made therapeutic mattresses and related patient safety products, has appointed Dorian Drake International as its exclusive export representative for Latin America and the Caribbean. Dorian Drake will as act as Blue Chip Medical’s sales and marketing arm in the region, with a special focus on developing distribution and promoting the ...
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OrthoPediatrics Announces Entry into a Distribution Agreement with SeaSpine to Exclusively Distribute the 7D Surgical FLASH Navigation Platform for Pediatric Applications
Enables OrthoPediatrics to Further Address Full Patient Continuum of Care for Pediatric Orthopedic Surgeons with Market-Leading, Radiation-Free Navigation Technology WARSAW, Ind., Sept. 09, 2021 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today ...
By 7D Surgical
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Enalare Therapeutics Receives Rare Pediatric Disease Designation for Lead Compound ENA-001 for the Treatment of Apnea of Prematurity
Enalare Therapeutics Inc., a biopharmaceutical company dedicated to developing novel therapies for patients suffering from life threatening critical care conditions, announced today that the Food and Drug Administration (FDA) has granted it's lead compound, ENA-001, rare pediatric disease designation for the treatment of Apnea of Prematurity. Enalare is planning to develop this unique agnostic ...
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Biostage Hires David Green as Chief Executive Officer
Biostage, Inc. (OTCQB: BSTG) ("Biostage" or the "Company"), a biotechnology company with successful "first-in-human" experience in esophageal cancer and FDA approval to commence a clinical trial of its Biostage Esophageal Implant for esophageal disease, today announced it has hired David Green as its Chief Executive Officer and appointed Mr. Green as Chairman of the Board of Directors (the ...
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Enalare Therapeutics Receives Orphan Drug Designation From the U.S. FDA on ENA-001 for the Treatment of Apnea of Prematurity (AoP)
ENA-001, a New Chemical Entity (NCE) with a novel mechanism of action as an agnostic respiratory stimulant, has previously been granted Rare Pediatric Disease designation for the Treatment of AoP by the FDA, with eligibility for a priority review voucher (PRV). The compound is also being developed by Enalare for the treatment of post-operative respiratory depression and community drug overdose. ...
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