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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

Furthermore, many people underestimate their healthcare costs and do not save enough for annual expenditures, often leading to delays in treatment that can be detrimental to the patient. physicians are reporting feeling even more burnout (49%) in 2023 than they were in 2022 (45%). One in three (33%) U.S. While 20% of U.S.

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Healthcare Watch December 2023

PM360

The innovative company received FDA approval for its Magnetic Resonance Spectroscopy (MRS) platform, BrainSpec Core, to provide non-invasive measurement of brain chemistry to support the diagnostic process in the most common brain-related illnesses, including Alzheimer’s disease, multiple sclerosis, epilepsy, brain tumors, and more.

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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. This will lead to more pre-protocol design discussions between sponsors and CROs and regulatory bodies seeking input on new and potentially acceptable approaches to, for example, measure digital endpoints.

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Industry Briefs December 2023

PM360

A New Online Destination for HCPs HealthCentral Corporation , operator of leading digital platforms that serve patients living with chronic illness, their care partners, and health professionals, has announced the newest addition to its suite of HCP support sites: MedCentral.

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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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Healthcare Watch May 2023

PM360

Doctor Docs: Incorporating Climate Change into Physician Training A growing number of medical professionals across the U.S. This protein is the key to a natural mechanism to protect the body against blood clots when it cannot move,” stated Ole Frøbert, MD, PhD, study co-lead, in a press release.