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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

Does morphine use help with breathlessness?

24 Oct 2025

Treatment with oral morphine falls short of improving breathlessness due to cardiorespiratory conditions, as shown in a study.

Does morphine use help with breathlessness?

24 Oct 2025

EzPAP device bests noninvasive ventilation for hypercapnic COPD exacerbations

24 Oct 2025 by

In the treatment of patients with mild-to-moderate hypercapnic exacerbations of chronic obstructive pulmonary disease (COPD), the EzPAP positive airway pressure device works better than noninvasive ventilation at improving oxygen saturation levels and correcting respiratory acidosis, as shown in a study.

EzPAP device bests noninvasive ventilation for hypercapnic COPD exacerbations

24 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

Slow-tempo music intervention does nothing to improve delirium outcomes in ventilated patients

23 Oct 2025

A slow-tempo music intervention falls short of reducing the duration and severity of delirium in older patients on mechanical ventilation, according to a study.

Slow-tempo music intervention does nothing to improve delirium outcomes in ventilated patients

23 Oct 2025

Expanding the paradigm of consolidation therapy in NSCLC and SCLC

23 Oct 2025 by

Concurrent chemoradiotherapy (cCRT) has long been the standard curative-intent treatment for stage III unresectable non-small-cell lung cancer (NSCLC) and limited-stage (LS) small-cell lung cancer (SCLC). Following cCRT, consolidation therapy with durvalumab, an anti–PD-L1 antibody, is considered the standard-of-care (SoC) for patients with stage III NSCLC with no actionable genomic alterations. However, uncertainty exists on consolidation therapy options with EGFR tyrosine kinase inhibitors (TKIs) for patients with EGFR-mutant NSCLC, given the established evidence supporting their use in both resectable and unresectable stages, as well as in LS-SCLC. At an industry-sponsored symposium, Professor Te-Chun Hsia of the China Medical University Hospital in Taichung, Taiwan, discussed evolving consolidation therapy strategies in lung cancer, highlighting the role of osimertinib, a third-generation EGFR TKI, in patients with unresectable stage III EGFR-mutated NSCLC, and durvalumab in those with LS-SCLC.

Expanding the paradigm of consolidation therapy in NSCLC and SCLC

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

One in 10 hospitalized RSV patients has a concurrent acute CV event

21 Oct 2025 by

In a large cross-sectional study evaluating individuals hospitalized for respiratory syncytial virus (RSV), influenza, and COVID-19, one in 10 patients hospitalized for RSV had a concurrent acute cardiovascular (CV) event, and the odds of cardiac events were substantially higher in RSV vs COVID-19 hospitalizations.

One in 10 hospitalized RSV patients has a concurrent acute CV event

21 Oct 2025

Budesonide–formoterol reliever combo superior to salbutamol alone for mild asthma in kids

20 Oct 2025

The combination of inhaled corticosteroid budesonide plus formoterol appears to work better than the short-acting β2-agonist (SABA) salbutamol alone as reliever monotherapy for mild asthma in children, being associated with lower incidence of asthma attacks in a randomized controlled trial (RCT).

Budesonide–formoterol reliever combo superior to salbutamol alone for mild asthma in kids

20 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

Does morphine use help with breathlessness?

Does morphine use help with breathlessness?

EzPAP device bests noninvasive ventilation for hypercapnic COPD exacerbations

EzPAP device bests noninvasive ventilation for hypercapnic COPD exacerbations

Infant antibiotic use ups risks of asthma, later infections

Infant antibiotic use ups risks of asthma, later infections

Slow-tempo music intervention does nothing to improve delirium outcomes in ventilated patients

Slow-tempo music intervention does nothing to improve delirium outcomes in ventilated patients

Expanding the paradigm of consolidation therapy in NSCLC and SCLC

Expanding the paradigm of consolidation therapy in NSCLC and SCLC

Ensitrelvir a viable alternative to available antivirals for COVID-19

Ensitrelvir a viable alternative to available antivirals for COVID-19

One in 10 hospitalized RSV patients has a concurrent acute CV event

One in 10 hospitalized RSV patients has a concurrent acute CV event

Budesonide–formoterol reliever combo superior to salbutamol alone for mild asthma in kids

Budesonide–formoterol reliever combo superior to salbutamol alone for mild asthma in kids