News & Updates

Original New Drug Application Approvals by US FDA (16-30 June 2024)

New drug applications approved by US FDA as of 16-30 June 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.

Ivonescimab plus chemo confers progression-free survival advantage in pretreated NSCLC

Ivonescimab plus chemotherapy has a tolerable safety profile and appears to significantly prolong progression-free survival (PFS) in patients with nonsmall cell lung cancer (NSCLC) whose disease progressed while receiving EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy, according to interim data from the phase III HARMONi-A study.

Certain antipsychotics tied to increased pneumonia risk

Specific antipsychotic drugs such as high-dose quetiapine, high- and medium-dose clozapine, and high-dose olanzapine appear to be associated with a heightened risk of pneumonia among patients with schizophrenia, as shown in a study.

Osimertinib extends PFS by 3.2 years in LAURA

Osimertinib extends progression-free survival (PFS) sevenfold longer than placebo in patients with unresectable stage III EGFR-mutated non–small cell lung cancer (NSCLC) following definitive chemoradiotherapy, as shown in the primary analysis of the phase III LAURA study presented at ASCO 2024. This breakthrough makes osimertinib the first EGFR inhibitor to show benefit in a stage III setting.

Retrospective study validates nirsevimab role against RSV in infants

A retrospective cohort study evaluating participants from Catalonia, Spain reinforces the potential of immunoprophylaxis with the novel monoclonal antibody nirsevimab in combating respiratory syncytial virus (RSV)-related outcomes in infants in the hospital and primary care settings.

Antibiotic and antiviral therapy in COVID-19 patients: Updates from ESCMID Global 2024

In COVID-19 patients, antibiotic therapy should be reserved only for suspected bacterial superinfections.

However, international data from over 1 million hospitalized COVID-19 patients across 65 countries showed that antibiotics were commonly prescribed empirically despite the low rates of reported bacterial co-infection.¹

VTE recurrence in chronic thromboembolic pulmonary hypertension higher with DOACs vs warfarin

For patients with chronic thromboembolic pulmonary hypertension (CTEPH) receiving anticoagulation treatment, direct oral anticoagulants (DOACs) appear to yield similar survival and bleeding outcomes but higher risk of venous thromboembolism (VTE) recurrence compared with warfarin, according to a study.

ctDNA EGFRm helps pinpoint who benefits from 1L osimertinib-chemo combo

Detectable EGFRm in plasma ctDNA prior to treatment may define a subgroup of patients with advanced EGFRm NSCLC who would derive the most benefit from the addition of chemo to 1L osimertinib, according to an exploratory analysis of FLAURA2 presented at AACR 2024