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Original New Drug Application Approvals by US FDA (16-31 December 2023)

03 Jan 2024

New drug applications approved by US FDA as of 16-31 December 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 (16-31 December 2023)

03 Jan 2024

Fluvoxamine of little benefit in mild-to-moderate COVID-19

02 Jan 2024

The use of fluvoxamine for outpatient treatment of mild-to-moderate COVID-19 falls short of reducing the duration of symptoms, as shown in the ACTIV-6 study.

Fluvoxamine of little benefit in mild-to-moderate COVID-19

02 Jan 2024

Severe outcomes more likely with Omicron XBB.1.16 in SG

29 Dec 2023 bởi

In a preliminary analysis, the risk of severe outcomes was higher in individuals infected with the Omicron XBB.1.16 subvariant compared with those who were infected with other subvariants such as the XBB.1.5 or XBB.1.9.

Severe outcomes more likely with Omicron XBB.1.16 in SG

29 Dec 2023

Minority healthcare workers more exposed to COVID-19‒related stressors

26 Dec 2023

Healthcare workers belonging to racial and ethnic minorities show greater exposure to several COVID-19‒related stressors, indicating a structural racism in the workforce, reports a study.

Minority healthcare workers more exposed to COVID-19‒related stressors

26 Dec 2023

Remdesivir shows no clear benefit in children with severe COVID-19

25 Dec 2023 bởi

The antiviral remdesivir offers no clear benefit in the treatment of children with severe COVID-19, falling short of reducing the time spent in high dependency or intensive care unit (HD/ICU), according to a study from Singapore.

Remdesivir shows no clear benefit in children with severe COVID-19

25 Dec 2023

Etranacogene dezaparvovec safe, effective for haemophilia B patients with HIV

23 Dec 2023 bởi

Treatment with etranacogene dezaparvovec demonstrates efficacy with a favourable safety profile in a subset of adult patients with severe or moderately severe haemophilia B living with HIV, according to a recent study presented at ASH 2023.

Etranacogene dezaparvovec safe, effective for haemophilia B patients with HIV

23 Dec 2023

Should KD patients be screened for Yersinia infection?

22 Dec 2023

Routine screening for Yersinia infection is not recommended for patients with Kawasaki disease (KD), suggests a recent study.

Should KD patients be screened for Yersinia infection?

22 Dec 2023

Routine testing for enterovirus CNS infection a must in febrile infants: study

21 Dec 2023

Infants with human nonpolio enterovirus (EV) central nervous system (CNS) infection often present without cerebrospinal fluid (CSF) pleocytosis, reports a study.