Positive high-level results of KOMET, the largest, global randomised double-blind placebo-controlled multicentre Phase III trial in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas… read more.
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced 48-week findings from the DOLCE study, sponsored by Fundación Huésped… read more.
Avapritinib is recommended, within its marketing authorisation, as an option for treating advanced systemic mastocytosis (including aggressive systemic mastocytosis, systemic mastocytosis with an associated haematological neoplasm and mast… read more.
Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced the FDA approval of the Varipulse Platform for the treatment of drug refractory paroxysmal Atrial Fibrillation… read more.
Bayer announced 510(k) clearance from the FDA for its Medrad Centargo CT Injection System, an innovative multi-patient injector that drives workflow efficiency with design features that integrate with… read more.
Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced the first clinical outcomes associated with the Shockwave… read more.
Intra-Cellular Therapies, Inc. announced positive results from Study 304 evaluating the efficacy and safety of lumateperone 42 mg for the prevention of relapse in adult patients with schizophrenia…. read more.
The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifically, the approval covers children aged… read more.
Lundbeck announced that Vyepti (eptinezumab) met the primary and all key secondary endpoints in SUNRISE, a phase III pivotal trial predominantly conducted in Asia evaluating the efficacy and… read more.
Johnson & Johnson announced that the European Commission (EC) has approved Edurant (rilpivirine) for the treatment of HIV-1 infection in adults and children weighing at least 25 kg… read more.
Edwards Lifesciences Corporation announced that the EVOQUE system demonstrated superiority compared to medical therapy alone for the one-year primary endpoint of the TRISCEND II trial. TRISCEND II is… read more.
Iterum Therapeutics plc announced that the FDA has approved Iterum’s new drug application for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs)… read more.
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