Ardena appoints Ariane de Ganck as Chief Scientific Officer
Ariane brings a strong track record within Ardena, including her leadership of the company’s drug product division since 2022
Ariane brings a strong track record within Ardena, including her leadership of the company’s drug product division since 2022
This certification confirms that the facility complies with Good Manufacturing Practice requirements as referred in the EC Directive
MeziKd delivered stronger response rates across multiple patient groups, including those receiving second- and third-line treatment and patients with higher-risk disease
The expanded indication is backed by data from the Phase 3 AMPLIFY and GLOW trials and the Phase 2 CAPTIVATE study,
The findings mark one of the longest progression-free survival outcomes ever reported in advanced lung cancer
The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market
The programme evaluated anselamimab as a first-line add-on to standard plasma cell dyscrasia therapy in patients with advanced cardiac AL amyloidosis
The study tracked patients for more than five years (median 60.7 months), with protection against disease returning emerging in under four months and continuing long term
The filing is backed by results from the pivotal SERENA-6 Phase III trial
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