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Pediatric Product Articles & Analysis: Older

6 news found

Enalare Therapeutics Receives Orphan Drug Designation From the U.S. FDA on ENA-001 for the Treatment of Apnea of Prematurity (AoP)

Enalare Therapeutics Receives Orphan Drug Designation From the U.S. FDA on ENA-001 for the Treatment of Apnea of Prematurity (AoP)

Orphan Drug Designation is granted to drugs or biological products for the treatment of rare diseases or conditions that impact fewer than 200,000 people in the United States. ...

ByEnalare Therapeutics Inc.


Enalare Therapeutics Receives Rare Pediatric Disease Designation for Lead Compound ENA-001 for the Treatment of Apnea of Prematurity

Enalare Therapeutics Receives Rare Pediatric Disease Designation for Lead Compound ENA-001 for the Treatment of Apnea of Prematurity

Enalare is planning to develop this unique agnostic respiratory stimulant for a multitude of indications related to acute respiratory depression, including for neonates experiencing Apnea of Prematurity. Under the FDA's rare pediatric disease designation program, the FDA may grant a priority review voucher to a sponsor who receives a product approval for a rare ...

ByEnalare Therapeutics Inc.


Biostage Hires David Green as Chief Executive Officer

Biostage Hires David Green as Chief Executive Officer

In China, an important market for the Company's products, there were over 250,000 new cases of esophageal cancer and over 200,000 deaths in 2010 (reference 2). ...

ByHarvard Apparatus Regenerative Technology, Inc. formely known as Biostage, Inc.


OrthoPediatrics Announces Entry into a Distribution Agreement with SeaSpine to Exclusively Distribute the 7D Surgical FLASH Navigation Platform for Pediatric Applications

OrthoPediatrics Announces Entry into a Distribution Agreement with SeaSpine to Exclusively Distribute the 7D Surgical FLASH Navigation Platform for Pediatric Applications

(“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced they have entered into a distribution agreement with SeaSpine® Orthopedics Corporation, a wholly-owned subsidiary of SeaSpine Holdings Corporation (Nasdaq: SPNE), to exclusively distribute the 7D Surgical ...

By7D Surgical


Blue Chip Medical Appoints Dorian Drake International as its Export Representative for Latin America and the Caribbean

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. ...

ByDorian Drake International


3DBio Therapeutics Receives FDA Rare Pediatric Disease Designation for AuriNovo™ for Ear Reconstruction in Microtia Patients

3DBio Therapeutics Receives FDA Rare Pediatric Disease Designation for AuriNovo™ for Ear Reconstruction in Microtia Patients

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. ...

By3DBio Therapeutics

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