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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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EndoStim Receives FDA Breakthrough Device Designation for the EndoStim System for the Treatment of Drug Refractory GERD

Legacy MEDSearch

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. The EndoStim System consists of an implantable neurostimulation device and lead placed via a quick, minimally-invasive laparoscopic procedure. About the EndoStim System. About EndoStim.

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How Pharmacogenomics may finally realise its promise

pharmaphorum

Identifying those variations helps to target medication changes that can be safer and more effective. Some people are hyper-metabolisers, meaning a drug may move too fast through their system and not deliver the intended therapeutic effect; while others may metabolise a drug too slowly, triggering an adverse side effect or overdose.

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FDA makes moves to advance ALS research ahead of upcoming Amylyx AdCom

Pharmaceutical Technology

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. In the US, most physicians can only spend a day a week, which isn’t efficient, she says. “We

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Surviving Cancer And Making An Impact To Cancer Patients’ Lives With Rob Ciaramitaro

Evolve Your Success

It is primary care physicians who are looking into the general population to help determine if there’s disease there. I was thankful and blessed to connect with one of the leading researchers on my subtype. I had relationships with physicians because of my career, thankfully. Eat a whole-food diet as much as possible.

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Ep. 001 – John Mack Podcast Transcript

Pharma Marketing Network

I was at Physicians Online at the time. You know, in November 2009, the FDA held a public hearing about the promotion of Food and Drug Administrative Related Regulated Medical Products, using the internet and social media tools. And I had experience doing these highlight bulletins when my work with RJ at the physicians’ online.

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Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

5 Subsequently, transplant centres administering CAR T cells in various pharma-sponsored clinical trials had to establish multi-disciplinary teams, including not just haematologists and oncologists but also intensive-care physicians and nurses, nephrologists, neurologists, pharmacists and others. US Food and Drug Administration.