Rocket Pharmaceuticals (RCKT) announced that it has received clearance from the FDA for the company’s investigational new drug application for RP-A701, an AAVrh.74-based gene therapy candidate for the ...

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The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...

Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items ...

FDA decision will enable Iksuda to expand its ongoing clinical trial in the US, Australia and Singapore Preliminary data from an ongoing dose-escalation study of IKS014 has shown meaningful clinical ...

New details of how a Victorian man, accused of organised crime links, allegedly attempted to store over 200kg of cocaine at a ...

A novel oral peptide PN-477o with once-daily dosing, high potency and activation of glucagon-like peptide-1 (GLP-1), ...

Monotherapy efficacy and safety profile provided backbone for clinical development strategy in 1L combination with nivolumab plus chemotherapy ...

During June, investigators reported new data that has advanced the treatment landscape for lung cancer, including new FDA ...

FDA issues a complete response letter for oxylanthanum carbonate, a treatment for hyperphosphatemia in patients with chronic ...

Nicox completed the Denali Phase 3 trial for NCX 470, targeting open-angle glaucoma and ocular hypertension. NCX 470 combines ...

The FDA plans to approve selected high-priority drug application submissions in 1 to 2 months rather than 10 to 12.