Iterum Therapeutics plc

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

Iterum Therapeutics plc’s Orlynvah (sulopenem etzadroxil and probenecid) has become the first new antibiotic for uncomplicated urinary tract infections (uUTI) in women in two decades and the first ora