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Original New Drug Application Approvals by US FDA (16-30 September 2025)

31 Oct 2025

New drug applications approved by US FDA as of 16-30 September 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 (16-30 September 2025)

31 Oct 2025

Colchicine flops for long COVID treatment

29 Oct 2025

Treatment with colchicine does not appear to improve functional capacity, respiratory function, or inflammatory markers in adults with long COVID, as shown in a study.

Colchicine flops for long COVID treatment

29 Oct 2025

Obesity linked to COVID-19 severity in children during pre-Omicron wave

28 Oct 2025 by

A recent study has found that individuals with obesity had more severe COVID-19 during the ancestral and pre-Omicron waves, but not during the Omicron wave.

Obesity linked to COVID-19 severity in children during pre-Omicron wave

28 Oct 2025

Neurologic manifestations common in children with COVID-19

28 Oct 2025

Children hospitalized with acute SARS-CoV-2 and multisystem inflammatory syndrome (MIS) tend to experience neurologic manifestations, according to a study in Indonesia.

Neurologic manifestations common in children with COVID-19

28 Oct 2025

Older adults get renoprotection from flu vaccine

27 Oct 2025 by

Influenza vaccination appears to provide a protective benefit against acute kidney injury (AKI) in older adults, according to a study.

Older adults get renoprotection from flu vaccine

27 Oct 2025

Faecal transplant blocks UTI return

25 Oct 2025 by

Faecal microbiota transplantation has been shown to help resolve recurrent urinary tract infections in a small study.

Faecal transplant blocks UTI return

25 Oct 2025

Delivery type, birth weight predict onset of Kawasaki disease

23 Oct 2025

Several factors may influence the development of Kawasaki disease (KD) in children, and these include delivery type and birth weight, among others.

Delivery type, birth weight predict onset of Kawasaki disease

23 Oct 2025

Infant antibiotic use ups risks of asthma, later infections

23 Oct 2025 by

Early use of antibiotics among children may lead to several health concerns, including asthma and later infections during childhood years, suggests a study.

Infant antibiotic use ups risks of asthma, later infections

23 Oct 2025

PCV21 shows promise as alternative to PCV13 for infants

23 Oct 2025 by

Three formulations of the 21-valent pneumococcal conjugate vaccine (PCV21) have shown favourable immunogenicity and acceptable tolerability profile among toddlers and infants, when compared with PCV13, in a phase II study.

PCV21 shows promise as alternative to PCV13 for infants

23 Oct 2025

Ensitrelvir a viable alternative to available antivirals for COVID-19

21 Oct 2025 by

The investigational oral antiviral ensitrelvir shows potent antiviral activity in COVID-19, although its effect is slightly weaker than that of ritonavir-boosted nirmatrelvir, according to the ongoing, phase II, randomized controlled, adaptive pharmacometric platform PLATCOV trial.

Ensitrelvir a viable alternative to available antivirals for COVID-19

21 Oct 2025

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Original New Drug Application Approvals by US FDA (16-30 September 2025)

Original New Drug Application Approvals by US FDA (16-30 September 2025)

Colchicine flops for long COVID treatment

Colchicine flops for long COVID treatment

Obesity linked to COVID-19 severity in children during pre-Omicron wave

Obesity linked to COVID-19 severity in children during pre-Omicron wave

Neurologic manifestations common in children with COVID-19

Neurologic manifestations common in children with COVID-19

Older adults get renoprotection from flu vaccine

Older adults get renoprotection from flu vaccine

Faecal transplant blocks UTI return

Faecal transplant blocks UTI return

Delivery type, birth weight predict onset of Kawasaki disease

Delivery type, birth weight predict onset of Kawasaki disease

Infant antibiotic use ups risks of asthma, later infections

Infant antibiotic use ups risks of asthma, later infections

PCV21 shows promise as alternative to PCV13 for infants

PCV21 shows promise as alternative to PCV13 for infants

Ensitrelvir a viable alternative to available antivirals for COVID-19

Ensitrelvir a viable alternative to available antivirals for COVID-19