EU to withdraw Levamisole medicines over risk of rare, deadly brain disorder
The recommendation is based on new data from continuous safety monitoring of medicines in the EU
The recommendation is based on new data from continuous safety monitoring of medicines in the EU
Ind-Ra expects chronic therapies to outpace IPM as compliance improves and lifestyle diseases rise
The upcoming Phase I trial will test the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers and determine the optimal dosing for future studies
The Phase 1 single and multiple ascending dose study is set to begin dosing in early Q1 2026
This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million
ADHD is a common, chronic neurodevelopmental disorder that often begins in childhood and can persist into adulthood
Despite some promising subgroup signals, the company indicated it will not pursue further psychiatric trials
The multicenter study will enroll 75 patients across 16 sites in Germany, Bulgaria, Poland, and Spain
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
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