AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1
The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population
The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population
The facility has been classified as Voluntary Action Indicated
Corning and SGD Pharma formed JV in June 2023 to expand pharmaceutical manufacturing in India
Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion
Sessions will cover process mapping, cost optimisation, data-driven decision-making, cybersecurity, and sustainable manufacturing practices
Agency initiates safety label change and notifies physicians of possible link
No post-injection Delirium/Sedation Syndrome (PDSS) observed through 56 weeks
Clinical evidence has consistently highlighted lacosamide’s efficacy and safety.
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