Indoco's formulation plant at Baddi receives EU GMP certification
This certification confirms that the facility complies with Good Manufacturing Practice requirements as referred in the EC Directive
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 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 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
The programme evaluated anselamimab as a first-line add-on to standard plasma cell dyscrasia therapy in patients with advanced cardiac AL amyloidosis
The filing is backed by results from the pivotal SERENA-6 Phase III trial
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