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FDA accepts resubmission of Ardelyx’s NDA for XPHOZAH

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

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Healthcare Watch April 2023

PM360

Med Device Department: Medicare Sets Precedent for Virtual Reality Therapeutic Payments In November 2021, the FDA approved a virtual reality (VR) therapy that provides an immersive experience for relieving chronic lower back pain. CMS factored in the efficacy of the device as well as its safety beyond the use of opioids. In the U.S.,

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Healthcare Watch October 2023

PM360

Of the eight FDA-approved weight loss drugs on the market, these two are making waves for doctors who believe they represent “a new era for weight loss medications,” and “changing options and giving hope.” “They are effective but too expensive for the majority of patients, even with insurance coverage,” said one primary care physician (PCP).

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Curavit’s crystal ball – how will 2023 drive meaningful changes in clinical research

pharmaphorum

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept.

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FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

Pharma Leaders

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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FDA approves Ipsen’s Bylvay for cholestatic pruritus due to ALGS

Pharmaceutical Technology

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). Ipsen is also seeking marketing approval from the European Medicines Agency, with a final decision expected in the second half of 2023.

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Industry Briefs December 2023

PM360

“We’re now leveraging our expertise in communicating with healthcare professionals to deliver essential information and practical tools to physicians and other healthcare providers to help them address the challenges faced by patients with chronic illness.”