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Results For "pediatric"

242 News Found

Abbott wins FDA & CE nod for groundbreaking premature infant heart device
Medical Device | December 22, 2025

Abbott wins FDA & CE nod for groundbreaking premature infant heart device

The system is intended for some of the tiniest patients—premature infants weighing as little as two pounds


FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
Biopharma | December 16, 2025

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease


Sanofi secures two breakthrough nods in China for rare blood disorders
News | December 16, 2025

Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia


Caplin Steriles gets FDA final approval for Acetaminophen Injection, infusion bags
News | December 09, 2025

Caplin Steriles gets FDA final approval for Acetaminophen Injection, infusion bags

Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older


Capricor's cell therapy shows breakthrough results in Duchenne muscular dystrophy trial
Clinical Trials | December 09, 2025

Capricor's cell therapy shows breakthrough results in Duchenne muscular dystrophy trial

It's a development that marks a potential breakthrough for people living with the rare and debilitating disease Duchenne muscular dystrophy (DMD)


Praxis Precision hits milestone in fight against rare paediatric seizures
Clinical Trials | December 08, 2025

Praxis Precision hits milestone in fight against rare paediatric seizures

The EMBOLD study evaluated relutrigine for patients with SCN2A and SCN8A developmental and epileptic encephalopathies


Belite Bio reports landmark phase 3 success for Stargardt Disease therapy
Clinical Trials | December 03, 2025

Belite Bio reports landmark phase 3 success for Stargardt Disease therapy

Seeing well-controlled Phase 3 data that shows a marked slowing of lesion growth in Stargardt disease is deeply encouraging


Renalys Pharma reports major phase III success for Sparsentan in Japanese IgA nephropathy patients
Clinical Trials | November 28, 2025

Renalys Pharma reports major phase III success for Sparsentan in Japanese IgA nephropathy patients

The study, which enrolled 35 Japanese patients, evaluated the percent change from baseline in the 24-hour urine protein-to-creatinine ratio


Investors pile in as Cordance secures oversubscribed seed round for brain-cancer tech
News | November 27, 2025

Investors pile in as Cordance secures oversubscribed seed round for brain-cancer tech

The fresh capital will propel Cordance into its first-in-human clinical trial


Novartis scores FDA nod for game-changing SMA treatment
Biotech | November 26, 2025

Novartis scores FDA nod for game-changing SMA treatment

Itvisma is a one-time, fixed-dose therapy designed to tackle the genetic root cause of SMA