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Original New Drug Application Approvals by US FDA (16-31 August 2024)

19 Sep 2024

New drug applications approved by US FDA as of 16-31 August 2024 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (16-31 August 2024)

19 Sep 2024

Automated insulin pump system does not alter energy, nutrient intake in T1D patients

18 Sep 2024 by

Use of the automated insulin delivery (AID) system delivers better glycaemic control in people with type 1 diabetes (T1D). However, switching to the Minimed 780G insulin pump system does not lead to notable changes in energy and nutrient intake in this population, according to a study.

Automated insulin pump system does not alter energy, nutrient intake in T1D patients

18 Sep 2024

Canagliflozin lowers HbA1c in children with T2D

16 Sep 2024 by

Treatment with canagliflozin results in clinically meaningful reductions in glycated haemoglobin (HbA1c), when compared with placebo, in children and adolescents with type 2 diabetes (T2D), as shown by the results of a phase III study presented at EASD 2024.

Canagliflozin lowers HbA1c in children with T2D

16 Sep 2024

Investigational drug for paediatric congenital adrenal hyperplasia succeeds in phase III trial

14 Sep 2024 by

The novel oral corticotropin-releasing factor type 1 receptor antagonist crinecerfont helps supress androstenedione levels in children with congenital adrenal hyperplasia (CAH) and reduce the need for glucocorticoids, as shown in the phase III CAHtalyst Pediatric trial.

Investigational drug for paediatric congenital adrenal hyperplasia succeeds in phase III trial

14 Sep 2024

Bedtime screen use harms sleep in youths

14 Sep 2024

Using screens once already in bed appears to have a negative impact on sleep in young people, especially when screen time involves gaming or multitasking, according to a study.

Bedtime screen use harms sleep in youths

14 Sep 2024

Nirsevimab cuts risk of hospitalization for RSV-associated bronchiolitis

12 Sep 2024 by

The ENVIE* study demonstrates the real-world effectiveness of nirsevimab against hospitalization for bronchiolitis associated with respiratory syncytial virus (RSV) among infants <12 months of age in France.

Nirsevimab cuts risk of hospitalization for RSV-associated bronchiolitis

12 Sep 2024

Early diagnosis, antifungal therapy improve outcomes in invasive fungal sinusitis

11 Sep 2024

Children with invasive fungal sinusitis may benefit from early diagnosis, aggressive surgical intervention, and combined antifungal therapy to achieve better outcomes, suggests a study.

Early diagnosis, antifungal therapy improve outcomes in invasive fungal sinusitis

11 Sep 2024

Sulfamethoxazole-trimethoprim plus rifampicin most used treatment for brucellosis

10 Sep 2024

In the treatment of children with brucellosis, the most prescribed antibiotic therapy is sulfamethoxazole-trimethoprim plus rifampicin, reports a study.

Sulfamethoxazole-trimethoprim plus rifampicin most used treatment for brucellosis

10 Sep 2024

Pyomyositis a challenging diagnosis in nontropical countries

09 Sep 2024 by

Diagnosis of pyomyositis, a bacterial muscle infection, among hospitalized children and adolescents with musculoskeletal pain remains difficult for many clinicians and requires greater awareness, according to a recent study.

Pyomyositis a challenging diagnosis in nontropical countries

09 Sep 2024

Birth month predicts severe RSV infection in infants

08 Sep 2024 by

Infants born prior to or within the early weeks of a respiratory syncytial virus (RSV) epidemic must be prioritized to prevent the development of a clinical severe infection, suggests a study that used machine-learning algorithms.

Birth month predicts severe RSV infection in infants

08 Sep 2024

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Original New Drug Application Approvals by US FDA (16-31 August 2024)

Original New Drug Application Approvals by US FDA (16-31 August 2024)

Automated insulin pump system does not alter energy, nutrient intake in T1D patients

Automated insulin pump system does not alter energy, nutrient intake in T1D patients

Canagliflozin lowers HbA1c in children with T2D

Canagliflozin lowers HbA1c in children with T2D

Investigational drug for paediatric congenital adrenal hyperplasia succeeds in phase III trial

Investigational drug for paediatric congenital adrenal hyperplasia succeeds in phase III trial

Bedtime screen use harms sleep in youths

Bedtime screen use harms sleep in youths

Nirsevimab cuts risk of hospitalization for RSV-associated bronchiolitis

Nirsevimab cuts risk of hospitalization for RSV-associated bronchiolitis

Early diagnosis, antifungal therapy improve outcomes in invasive fungal sinusitis

Early diagnosis, antifungal therapy improve outcomes in invasive fungal sinusitis

Sulfamethoxazole-trimethoprim plus rifampicin most used treatment for brucellosis

Sulfamethoxazole-trimethoprim plus rifampicin most used treatment for brucellosis

Pyomyositis a challenging diagnosis in nontropical countries

Pyomyositis a challenging diagnosis in nontropical countries

Birth month predicts severe RSV infection in infants

Birth month predicts severe RSV infection in infants