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Bayer wins FDA breakthrough therapy designation for NSCLC candidate

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Bayer for its non-small cell lung cancer …

FDA clears PK Med to streamline gout injectable to Phase II

France-based biotechnology company PK Med has received clearance from the US Food and Drug Administration (FDA) to advance its injectable …

Biogen receives EMA CHMP recommendation for ALS drug Qalsody

Biogen has received a positive opinion from the European Medicines Agency (EMA) committee recommending approval for Qalsody (tofersen) to treat …

Streamlining supply chain operations in focus at Clinical Trial Supply Europe 2024 

How can true supply chain agility be achieved in response to increasingly complex trial demands?  This question will be explored at …

Merck’s Keytruda regimen gains positive EMA CHMP opinion

Merck (MSD)'s anti-programmed death receptor-1 (PD-1) therapy Keytruda has received a positive opinion from the Committee for Medicinal Products for …