FDA nod to first oral single-dose treatment for gonorrhea
The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership
The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership
Ryght AI tackles these hurdles with its AI Site Twin platform
The reform is set to modernise how medicines are developed, authorised, and made available across the EU
The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort
Alphyn is developing Zabalafin Hydrogel as the first therapy to simultaneously tackle the interconnected drivers of AD
The inspection concluded with one minor observation in Form 483
Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states
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