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Original New Drug Application Approvals by US FDA (1-15 August 2024)

30 Aug 2024

New drug applications approved by US FDA as of 1-15 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 (1-15 August 2024)

30 Aug 2024

Haemostatic powder spray safely stops acute upper GI bleeds in children

29 Aug 2024 by

The use of a powder agent, either as monotherapy or in combination with other conventional therapy, appears to be safe and effective for endoscopic haemostasis in children with acute upper gastrointestinal (GI) bleeding (UGIB), according to real-world data from Singapore.

Haemostatic powder spray safely stops acute upper GI bleeds in children

29 Aug 2024

Dad’s preconception HBV infection tied to baby’s heart defects

28 Aug 2024 by

A preconception history of hepatitis B virus (HBV) infection among fathers carries an increased risk of congenital heart disease (CHD) in offspring, as shown in a study.

Dad’s preconception HBV infection tied to baby’s heart defects

28 Aug 2024

Gestational diabetes linked to altered gut microbiome and larger head circumference in male offspring

28 Aug 2024 by

Gestational diabetes mellitus (GDM) not only disrupts the gut microbiome of mothers and their infants, but is also linked to increased head circumference in male offspring, researchers from the Chinese University of Hong Kong (CUHK) have shown.

Gestational diabetes linked to altered gut microbiome and larger head circumference in male offspring

28 Aug 2024

3-in-1 combo test supports differential diagnosis of COVID-19 and Flu A&B for timely treatment

28 Aug 2024

Rapid antigen tests have become valuable for identifying active COVID-19 infections and facilitating effective control measures. However, with the concurrent upswing in COVID and flu (influenza) cases, clinicians need a test that simultaneously detects COVID-19 and flu to support timely and accurate diagnosis and treatment.

3-in-1 combo test supports differential diagnosis of COVID-19 and Flu A&B for timely treatment

28 Aug 2024

Many infant products sold in Southeast Asia are ultraprocessed: study

27 Aug 2024 by

Several products in the Southeast Asia (SEA) region that are being marketed for infants and young children are considered ultraprocessed and contain certain additives, reveals a recent study. In addition, many of these additives are banned by Codex Alimentarius.

Many infant products sold in Southeast Asia are ultraprocessed: study

27 Aug 2024

Rise in SSB intake among children raises concerns

26 Aug 2024 by

For the past three decades, intakes of sugar-sweetened beverages (SSBs) among children and adolescents across 185 countries have increased by nearly a quarter, reports a study. This increase matches the rise in obesity prevalence among young people worldwide.

Rise in SSB intake among children raises concerns

26 Aug 2024

Emodepside takes on hookworm infections with high efficacy but increased AEs

24 Aug 2024 by

Emodepside appears to be efficacious in the treatment of hookworm infections, with cure rates that surpass those achieved with albendazole but at the expense of increased adverse events (AEs), as shown in a phase IIb study.

Emodepside takes on hookworm infections with high efficacy but increased AEs

24 Aug 2024

Sunlight intensity matters in outdoor interventions to prevent myopia in children

22 Aug 2024

New research suggests that the intensity of sunlight, not just the amount of time spent outdoors, is crucial for preventing myopia in children.

Sunlight intensity matters in outdoor interventions to prevent myopia in children

22 Aug 2024

COVID-19 vaccine safe to administer in first trimester of pregnancy, study says

21 Aug 2024

Among pregnant women, exposure to mRNA COVID-19 vaccine in the first trimester does not appear to contribute to an increased risk of selected major structural birth defects, according to a retrospective study.

COVID-19 vaccine safe to administer in first trimester of pregnancy, study says

21 Aug 2024

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Original New Drug Application Approvals by US FDA (1-15 August 2024)

Original New Drug Application Approvals by US FDA (1-15 August 2024)

Haemostatic powder spray safely stops acute upper GI bleeds in children

Haemostatic powder spray safely stops acute upper GI bleeds in children

Dad’s preconception HBV infection tied to baby’s heart defects

Dad’s preconception HBV infection tied to baby’s heart defects

Gestational diabetes linked to altered gut microbiome and larger head circumference in male offspring

Gestational diabetes linked to altered gut microbiome and larger head circumference in male offspring

3-in-1 combo test supports differential diagnosis of COVID-19 and Flu A&B for timely treatment

3-in-1 combo test supports differential diagnosis of COVID-19 and Flu A&B for timely treatment

Many infant products sold in Southeast Asia are ultraprocessed: study

Many infant products sold in Southeast Asia are ultraprocessed: study

Rise in SSB intake among children raises concerns

Rise in SSB intake among children raises concerns

Emodepside takes on hookworm infections with high efficacy but increased AEs

Emodepside takes on hookworm infections with high efficacy but increased AEs

Sunlight intensity matters in outdoor interventions to prevent myopia in children

Sunlight intensity matters in outdoor interventions to prevent myopia in children

COVID-19 vaccine safe to administer in first trimester of pregnancy, study says

COVID-19 vaccine safe to administer in first trimester of pregnancy, study says