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Original New Drug Application Approvals by US FDA (01-15 October 2023)

18 Oct 2023

New drug applications approved by US FDA as of 01-15 October 2023 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 (01-15 October 2023)

18 Oct 2023

Bivalent mRNA vaccine confers protection against SARS-COV-2 infection in young children

18 Oct 2023 bởi

Bivalent COVID-19 vaccine conferred protection against SARS-COV-2 infection among children and adolescents aged 5–11 years, according to a recent study presented at IDWeek 2023.

Bivalent mRNA vaccine confers protection against SARS-COV-2 infection in young children

18 Oct 2023

Dapagliflozin cuts HbA1c in paediatric T2D

17 Oct 2023 bởi

Dapagliflozin reduced HbA_1c by 1.03 percentage points more than placebo in children and adolescents with type 2 diabetes (T2D), while saxagliptin showed no significant reduction vs placebo in the phase III T2NOW trial presented at EASD 2023.

Dapagliflozin cuts HbA1c in paediatric T2D

17 Oct 2023

PPI use poses risk of serious infections in kids

12 Oct 2023

Use of proton pump inhibitor (PPI) appears to contribute to an increased risk of serious infections in children, as reported in a study.

PPI use poses risk of serious infections in kids

12 Oct 2023

Age, motion sickness tied to chemo-induced nausea, vomiting in children with cancer

11 Oct 2023

In children with cancer receiving chemotherapy, factors such as age and susceptibility to motion sickness are associated with the risk of acute chemotherapy-induced nausea (CIN), reports a study.

Age, motion sickness tied to chemo-induced nausea, vomiting in children with cancer

11 Oct 2023

Foetal echocardiogram precisely detects congenital heart diseases

11 Oct 2023 bởi

Use of foetal echocardiograms results in an accurate diagnosis of congenital heart diseases (CHDs), with good concordance between pre- and postnatal diagnoses, according to a Singapore study.

Foetal echocardiogram precisely detects congenital heart diseases

11 Oct 2023

Pott’s puffy tumor not uncommon in teens with prolonged headache

10 Oct 2023

A recent study recommends having a high index of suspicion for Pott’s puffy tumour (PPT), a rare complication of frontal sinusitis, among adolescents who present with prolonged headache or frontal swelling.

Pott’s puffy tumor not uncommon in teens with prolonged headache

10 Oct 2023

Original New Drug Application Approvals by US FDA (15-30 September 2023)

10 Oct 2023

New drug applications approved by US FDA as of 15-30 September 2023 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 (15-30 September 2023)

10 Oct 2023

H pylori a usual finding during endoscopy for other paediatric GI diseases

09 Oct 2023

A common incidental discovery during upper endoscopy for the diagnosis of common paediatric gastrointestinal (GI) diseases is Helicobacter pylori (H pylori) gastritis, a recent study has revealed. However, indications for treatment are not clear and warrant further research.

H pylori a usual finding during endoscopy for other paediatric GI diseases

09 Oct 2023

Renal relapse in childhood-onset lupus nephritis: When? Who’s at risk?

06 Oct 2023 bởi

A 20-year retrospective study in Hong Kong has shown that renal relapse generally occurs within the first 5 years after diagnosis of childhood-onset lupus nephritis (cLN) in Chinese patients. The risk of renal relapse is higher in those diagnosed at young age, those failing to achieve complete remission (CR) 12 months after induction therapy, and those receiving maintenance therapy other than mycophenolate mofetil (MMF).

Renal relapse in childhood-onset lupus nephritis: When? Who’s at risk?

06 Oct 2023

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Original New Drug Application Approvals by US FDA (01-15 October 2023)

Original New Drug Application Approvals by US FDA (01-15 October 2023)

Bivalent mRNA vaccine confers protection against SARS-COV-2 infection in young children

Bivalent mRNA vaccine confers protection against SARS-COV-2 infection in young children

Dapagliflozin cuts HbA1c in paediatric T2D

Dapagliflozin cuts HbA1c in paediatric T2D

PPI use poses risk of serious infections in kids

PPI use poses risk of serious infections in kids

Age, motion sickness tied to chemo-induced nausea, vomiting in children with cancer

Age, motion sickness tied to chemo-induced nausea, vomiting in children with cancer

Foetal echocardiogram precisely detects congenital heart diseases

Foetal echocardiogram precisely detects congenital heart diseases

Pott’s puffy tumor not uncommon in teens with prolonged headache

Pott’s puffy tumor not uncommon in teens with prolonged headache

Original New Drug Application Approvals by US FDA (15-30 September 2023)

Original New Drug Application Approvals by US FDA (15-30 September 2023)

H pylori a usual finding during endoscopy for other paediatric GI diseases

H pylori a usual finding during endoscopy for other paediatric GI diseases

Renal relapse in childhood-onset lupus nephritis: When? Who’s at risk?

Renal relapse in childhood-onset lupus nephritis: When? Who’s at risk?