News & Updates

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

New drug applications approved by US FDA as of 1-15 June 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.

Nirsevimab efficacy against RSV-LRTI hospitalization sustained at 6 months

Updated results from the phase IIIB HARMONIE trial demonstrate sustained efficacy of the long-acting monoclonal antibody nirsevimab against respiratory syncytial virus-associated lower respiratory tract infection (RSV-LRTI) hospitalization through day 181 post-dose.

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

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

Pimavanserin plus atomoxetine a promising treatment candidate for OSA

In the treatment of patients with obstructive sleep apnoea (OSA), using pimavanserin with atomoxetine appears to be beneficial, according to a small crossover study.

Nirmatrelvir-ritonavir shows benefits in immunocompromised individuals with COVID-19

Effective antiviral therapy is crucial for achieving sustained viral clearance and improving outcomes in patients with COVID-19, particularly among immunocompromised individuals.

At the recent ESCMID Global 2025 in Vienna, Austria, Ruth Mokgokong, a pharmacologist at Pfizer, UK, presented findings from the EPIC-IC trial, highlighting the benefits of an extended nirmatrelvir-ritonavir regimen in severely immunocompromised patients with symptomatic COVID-19.

Point-of-care testing detects RTIs faster than ever

Respiratory tract infections (RTIs) have been on the rise post-COVID-19 pandemic.

Due to high patient volumes, delayed clinic presentations, and prolonged lead times for PCR testing in the laboratory, doctors need a rapid and accurate diagnostic tool to help improve in-clinic patient workflow.