Baricitinib (Olumiant™): Now also available in the USA

Baricitinib (Olumiant™): Now also available in the USA

Baricitinib was first approved in the EU in February 2017 for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA);[1] this was followed shortly after by an approval in Japan in July of the same year.[2] Almost a year later, this Janus Kinase (JAK) inhibitor was approved by the US FDA in June 2018.[3] Continue reading “Baricitinib (Olumiant™): Now also available in the USA”

Neratinib (Nerlynx™): Negative opinion in the European Union

Neratinib (Nerlynx™): Negative opinion in the European Union

Neratinib was first approved in the US in July 2017.[1] However the eagerly awaited opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the future of the drug on the other side of the globe must have been disappointing for Puma Biotechnology. Continue reading “Neratinib (Nerlynx™): Negative opinion in the European Union”