As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...
Baar, 16 December 2024 – PolyPeptide Group AG (SIX: PPGN), a focused global CDMO for peptide-based active pharmaceutical ingredients, announces the start of production with the new large-scale SPPS ...
Suitable for freeze drying high potent products that require containment. Telstar Lyotris is a cGMP unit suited to clinical and small production scale batches of high-value pharmaceutical products ...
Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US.
Liver injuries also prompted the FDA to impose a partial clinical hold on Sanofi's BTK inhibitor tolebrutinib (SAR442168) earlier this year, holding up a programme that was a key part of its $3.7 ...