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Original-New-Drug-Application-Approvals-by-US-FDA--1-15-May-2025

29 May 2025

New drug applications approved by US FDA as of 1-15 May 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-May-2025

29 May 2025

β-lactam/β-lactamase inhibitor combination noninferior to piperacillin/tazobactam for pneumonia

28 May 2025

In the treatment of adults with hospital-associated (HABP) or ventilator-associated bacterial pneumonia (VABP), the β-lactam/β-lactamase inhibitor combination imipenem/cilastatin/relebactam appears to be as good as piperacillin/tazobactam, with similar safety profiles, according to a phase III trial.

β-lactam/β-lactamase inhibitor combination noninferior to piperacillin/tazobactam for pneumonia

28 May 2025

High, increasing BMI ups risk of adulthood OSA

26 May 2025 by

Individuals with high or continuously increasing BMI from childhood to middle age are at greater risk of developing obstructive sleep apnoea (OSA) later in life, reveals a study.

High, increasing BMI ups risk of adulthood OSA

26 May 2025

Personalizing upfront treatment options for advanced EGFRm NSCLC

26 May 2025 by

This article will summarize the latest developments in the first-line management of advanced EGFRm NSCLC and highlight key consideration factors.

Personalizing upfront treatment options for advanced EGFRm NSCLC

26 May 2025

VMR tied to severe COPD exacerbation

25 May 2025

Visceral fat-to-muscle ratio (VMR) can be used to predict the severe exacerbation of chronic obstructive pulmonary disease (COPD), suggests a study.

VMR tied to severe COPD exacerbation

25 May 2025

TrUST study heralds new era for TB diagnosis

21 May 2025 by

A suite of deep learning (DL) models to automate tuberculosis (TB) risk assessment from lung ultrasound (LUS) images fulfils the WHO criteria for a sputum-free TB triage test and outwits human experts in the TrUST study.

TrUST study heralds new era for TB diagnosis

21 May 2025

Dual therapy as good as three-drug HIV regimen in patients coinfected with TB

19 May 2025 by

In the treatment of HIV in individuals who are receiving rifampin-based therapy for tuberculosis, a two-drug antiretroviral (ART) regimen comprising double-dose dolutegravir plus lamivudine compares favourably with a three-drug regimen of efavirenz, tenofovir, and lamivudine in terms of suppressing viral load, as shown in a study.

Dual therapy as good as three-drug HIV regimen in patients coinfected with TB

19 May 2025

Meta-analysis strengthens case for awake prone positioning in COVID-19 with AHRF

17 May 2025 by

Placing awake COVID-19 patients with acute hypoxaemic respiratory failure (AHRF) in a prone position is an efficacious intervention in terms of both reducing mortality and preventing intubation, according to an individual participant data meta-analysis.

Meta-analysis strengthens case for awake prone positioning in COVID-19 with AHRF

17 May 2025

Updated EPIC-HR data bolster nirmatrelvir/ritonavir role against COVID-19

16 May 2025 by

Updated data from the EPIC-HR* trial show reduced duration of COVID-19 symptoms and utilization of healthcare resources with nirmatrelvir/ritonavir (NMV/r) in high-risk, unvaccinated, nonhospitalized, symptomatic adults with COVID-19.

Updated EPIC-HR data bolster nirmatrelvir/ritonavir role against COVID-19

16 May 2025

First-line tislelizumab plus chemo shows benefit in nsq-NSCLC with high PD-L1 expression

15 May 2025 by

First-line treatment with tislelizumab plus chemotherapy showed better survival outcomes and response among patients with locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC), particularly those with high PD-L1 expression, compared with chemotherapy alone, according to a subgroup analysis of the phase III RATIONALE-304 trial presented at ELCC 2025.

First-line tislelizumab plus chemo shows benefit in nsq-NSCLC with high PD-L1 expression

15 May 2025

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Original-New-Drug-Application-Approvals-by-US-FDA--1-15-May-2025

Original-New-Drug-Application-Approvals-by-US-FDA--1-15-May-2025

β-lactam/β-lactamase inhibitor combination noninferior to piperacillin/tazobactam for pneumonia

β-lactam/β-lactamase inhibitor combination noninferior to piperacillin/tazobactam for pneumonia

High, increasing BMI ups risk of adulthood OSA

High, increasing BMI ups risk of adulthood OSA

Personalizing upfront treatment options for advanced EGFRm NSCLC

Personalizing upfront treatment options for advanced EGFRm NSCLC

VMR tied to severe COPD exacerbation

VMR tied to severe COPD exacerbation

TrUST study heralds new era for TB diagnosis

TrUST study heralds new era for TB diagnosis

Dual therapy as good as three-drug HIV regimen in patients coinfected with TB

Dual therapy as good as three-drug HIV regimen in patients coinfected with TB

Meta-analysis strengthens case for awake prone positioning in COVID-19 with AHRF

Meta-analysis strengthens case for awake prone positioning in COVID-19 with AHRF

Updated EPIC-HR data bolster nirmatrelvir/ritonavir role against COVID-19

Updated EPIC-HR data bolster nirmatrelvir/ritonavir role against COVID-19

First-line tislelizumab plus chemo shows benefit in nsq-NSCLC with high PD-L1 expression

First-line tislelizumab plus chemo shows benefit in nsq-NSCLC with high PD-L1 expression