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Original New Drug Application Approvals by US FDA (1-15 February 2025)

10 Mar 2025

New drug applications approved by US FDA as of 1-15 February 2025 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 (1-15 February 2025)

10 Mar 2025

High-dose sulbactam tied to greater Cmid, PK-PD achievement

07 Mar 2025

Treatment with high-dose sulbactam leads to higher mid-dosing (Cmid) and pharmacokinetic-pharmacodynamic (PK-PD) achievement in paediatric patients, reports a study.

High-dose sulbactam tied to greater Cmid, PK-PD achievement

07 Mar 2025

Singaporean youths grapple with depression, anxiety

03 Mar 2025 bởi

A significant portion of Singapore’s youth are experiencing ‘severe’ to ‘extremely severe’ levels of depression and anxiety, according to the National Youth Mental Health Study.

Singaporean youths grapple with depression, anxiety

03 Mar 2025

APOSTEL 8: Tocolytic benefit for threatened preterm birth called into question

01 Mar 2025 bởi

In the management of threatened preterm birth between 30 and 34 weeks of gestation, atosiban falls short of improving neonatal outcomes when compared with placebo, according to the results of the APOSTEL 8 trial.

APOSTEL 8: Tocolytic benefit for threatened preterm birth called into question

01 Mar 2025

Aspirin for preeclampsia prophylaxis: Does dose matter?

27 Feb 2025 bởi

Doubling up on the daily aspirin dose of 81 mg appears to yield no significant protective effect against the incidence of preeclampsia in high-risk pregnancies, suggests findings from the ASAPP* study presented at SMFM 2025.

Aspirin for preeclampsia prophylaxis: Does dose matter?

27 Feb 2025

Prenatal COVID-19 infection, vaccination: Early child developmental concerns allayed

25 Feb 2025 bởi

Neither SARS-CoV-2 infection exposure nor COVID-19 vaccination during pregnancy poses a significant risk to early child development, as shown in a population-level study said to be the largest to date.

Prenatal COVID-19 infection, vaccination: Early child developmental concerns allayed

25 Feb 2025

High UPF intake linked to childhood obesity

22 Feb 2025 bởi

Consuming high amounts of ultraprocessed food (UPF) during early childhood is associated with obesity development, particularly in males, according to a Canadian study.

High UPF intake linked to childhood obesity

22 Feb 2025

Children with Crohn’s disease get relief with exclusion diet

21 Feb 2025 bởi

Exclusion diet appears to be safe and effective for inducing and maintaining remission in children with mild-to-moderate Crohn’s disease (CD), as shown in a small, single-centre study.

Children with Crohn’s disease get relief with exclusion diet

21 Feb 2025

Review pinpoints factors tied to teen depression in SG

20 Feb 2025 bởi

A systematic review of eight studies identified a range of factors associated with depression among adolescents in Singapore.

Review pinpoints factors tied to teen depression in SG

20 Feb 2025

MC4R agonist for obesity in young children scores high in phase III trial

20 Feb 2025

The melanocortin-4 receptor (MC4R) agonist setmelanotide demonstrates efficacy in the management of obesity in children younger than 6 years, according to the results of a phase III trial.

MC4R agonist for obesity in young children scores high in phase III trial

20 Feb 2025

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Original New Drug Application Approvals by US FDA (1-15 February 2025)

Original New Drug Application Approvals by US FDA (1-15 February 2025)

High-dose sulbactam tied to greater Cmid, PK-PD achievement

High-dose sulbactam tied to greater Cmid, PK-PD achievement

Singaporean youths grapple with depression, anxiety

Singaporean youths grapple with depression, anxiety

APOSTEL 8: Tocolytic benefit for threatened preterm birth called into question

APOSTEL 8: Tocolytic benefit for threatened preterm birth called into question

Aspirin for preeclampsia prophylaxis: Does dose matter?

Aspirin for preeclampsia prophylaxis: Does dose matter?

Prenatal COVID-19 infection, vaccination: Early child developmental concerns allayed

Prenatal COVID-19 infection, vaccination: Early child developmental concerns allayed

High UPF intake linked to childhood obesity

High UPF intake linked to childhood obesity

Children with Crohn’s disease get relief with exclusion diet

Children with Crohn’s disease get relief with exclusion diet

Review pinpoints factors tied to teen depression in SG

Review pinpoints factors tied to teen depression in SG

MC4R agonist for obesity in young children scores high in phase III trial

MC4R agonist for obesity in young children scores high in phase III trial