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Cancer Radiopharm. Dosage Guide

[ Price : $8.95]

FDA posts a new draft guidance entitled Oncology Therapeutic Radiopharmaceuticals (RPTs): Dosage Optimization During Clinical Deve...

Stealth Refiles NDA for Barth Syndrome Drug

[ Price : $8.95]

Stealth BioTherapeutics resubmits its NDA for elamipretide for treating Barth syndrome.

Court Orders FDA to Reconsider Vanda sNDA

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An appeals court rules that FDA improperly rejected Vanda Pharmaceuticals request for a hearing on its supplemental NDA for sleep ...

Advisory Panel Conflicts of Interest Low: Study

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A new study in JAMA finds that conflicts of interest among federal vaccine advisors had fallen to historic lows well before HHS se...

Tandem Recalls Insulin Pumps Due to Alarm Error

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Tandem Diabetes Care recalls (Class 1 device correction) certain t:slim X2 insulin pumps to address a potential speaker-related is...

Workshop on Patient Experience Data in Drug Development

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FDA announces a two-day virtual public workshop to address methodological challenges in using patient experience data in drug deve...

Wegovoy OKd for Metabolic Steatohepatitis

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FDA grants Novo Nordisk accelerated approval for a new Wegovy (semaglutide) indication for treating metabolic dysfunction-associat...

FDA OKs Tonix Drug for Fibromyalgia

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Tonix Pharmaceuticals gains approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a once-daily, non-opioid drug for treati...

FDA Delays Clinical Hold Review on Neurizon ALS Drug

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Staffing cuts and other administrative disorders leads to a review extension on a clinical hold review on Neurizon Therapeutics N...

FDA Alert on Baxter Novum Infusion Pumps

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FDA issues an alert on all Baxter Novum IQ Large Volume Pumps and Novum IQ Syringe Pumps after becoming aware of a company notific...