Iterum Therapeutics plc

GSK intends to file for US approval of the oral carbapenem antibiotic tebipenem-HBr to treat complicated urinary tract infections (cUTI) during the second half of 2025, three years after Spero Therape

The disruption of existing markets is a dominant ambition of the nearly 20 applications expecting US Food and Drug Administration action in March. The Pink Sheet ’s US FDA Performance Tracker shows

While the FDA is facing a disrupted and uncharted future, drug development offers a few certainties, including that oncology and neuroscience still dominate the novel agents seeking approval. But the

The US Food and Drug Administration maintained a high rate of complete response letter actions for novel agent applications in 2024, but recent history suggests that many of the 16 CRL recipients will