News & Updates

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 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.

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 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.

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.

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

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.

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