Pediatric Product Articles & Analysis
6 news found
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. ...
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 ...
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). ...
(“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 ...
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. ...
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. ...