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Device Evaluation, Treatment, and Explantation Recommendations (DETER): Review and Best Practices for Managing Neuromodulation Device Infections
23 Apr 2025 08:00 GMT
… medication withdrawal symptoms during emergent pump removal. Lab monitoring may aid treatment … , and treating neuromodulation device … Development Process
The Device Evaluation, Treatment … FDA, Food and Drug Administration; IPG, Implantable pulse generators; ITP …
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Oscotec to test cevidoplenib as 1st-line ITP drug through investigator-led trial
22 Apr 2025 06:27 GMT
… trial of cevidoplenib for second- and third-line treatment of immune thrombocytopenia (ITP … ), aims to confirm the drug’s … .”
Cevidoplenib is a novel drug candidate co-developed by Oscotec and Genosco …
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Genetic Sequencing Improves ITP Treatment
14 Mar 2025 04:55 GMT
Photo Credit: iStock.com/Tetiana Lazunova
Genomic sequencing identified pathogenic variants in patients with chronic immune thrombocytopenia (ITP), which could help clinicians improve diagnostic accuracy, according to a study published in Blood …
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Rilzabrutinib Receives Orphan Drug Designation for Two Rare Diseases
04 Apr 2025 13:45 GMT
…
Global Head of Development, Rare Diseases
“Orphan drug designation for these … action date for the FDA regulatory decision for ITP, which was granted … study identifier: NCT05002777) demonstrated that treatment with rilzabrutinib showed clinically meaningful …
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FDA awards ODD status to Sanofi’s rilzabrutinib for two rare conditions
04 Apr 2025 08:38 GMT
… Food and Drug Administration (FDA) orphan drug designation (ODD) to treat two … from a Phase IIb trial in wAIHA patients demonstrated … rate.
A Phase IIa trial in patients with IgG4- … ITP treatment in the EU, Japan and the US.
Sanofi rare diseases development …
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US FDA grants orphan drug designation to Sanofi’s rilzabrutinib, an oral, reversible BTK inhibitor for two rare diseases
04 Apr 2025 10:43 GMT
… Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib … head of development, rare diseases, said “Orphan drug designation for these … of certain other ITP treatments. Additionally, people living with ITP often experience …
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Rilzabrutinib Granted Orphan Drug Designation For Multiple Rare, Immune-Mediated Conditions
04 Apr 2025 20:10 GMT
… the treatment of immune thrombocytopenia (ITP); with a Prescription Drug … the Trial
Trial Name: Efficacy, Safety and Pharmacokinetics of … PhD, global head of development, rare diseases, at Sanofi … diseases with no approved medications. News Release. Released …
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Press Release: Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines
03 Apr 2025 05:00 GMT
… US Food and Drug Administration (FDA) has granted orphan drug designation to …
Global Head of Development, Rare Diseases
“Orphan drug designation for these … of certain other ITP treatments. Additionally, people living with ITP often experience easily …
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Why Is French Pharma Giant Sanofi Stock Trading Higher On Thursday?
03 Apr 2025 17:21 GMT
… . Food and Drug Administration (FDA) on Thursday granted orphan drug designation to Sanofi … SA‘s SNY rilzabrutinib.
The treatment is … use in immune thrombocytopenia (ITP).
Also Read: Pharmaceutical Firms Say UK Investment …
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Press Release: Rilzabrutinib Granted Orphan Drug Designation In The US For Two Rare Diseases With No Approved Medicines
03 Apr 2025 05:09 GMT
… US Food and Drug Administration (FDA) has granted orphan drug designation to …
Global Head of Development, Rare Diseases
“Orphan drug designation for these … of certain other ITP treatments. Additionally, people living with ITP often experience easily …