Approvals

AbbVie receives FDA approval of RINVOQ for moderate to severe rheumatoid arthritis

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).

Celgene’s Inrebic gets FDA approval for myelofibrosis

Celgene has secured approval from the US Food and Drug Administration (FDA) for its Inrebic (fedratinib) to treat adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.

Roche gets FDA nod for Rozlytrek to treat ROS1-positive NSCLC

Roche has secured approval from the US Food and Drug Administration (FDA) for its Rozlytrek (entrectinib) to treat adults with ROS1-positive and metastatic non-small cell lung cancer (NSCLC).

Janssen gets EC approval for two new indications of Imbruvica

The Janssen Pharmaceutical Companies of Johnson & Johnson has secured approval from the European Commission (EC) for two new indications of Imbruvica (ibrutinib).

FDA approves Daiichi Sankyo’s Turalio for rare joint tumour

Daiichi Sankyo has secured approval from the US Food and Drug Administration (FDA) for the use of Turalio (pexidartinib) for the treatment of symptomatic tenosynovial giant cell tumor (TGCT).

GSK gets EC approval for new administration options of asthma treatment Nucala

GlaxoSmithKline (GSK) has secured marketing authorisation from the European Commission (EC) for two new administration options of Nucala (mepolizumab) to treat patients with severe eosinophilic asthma.

Bayer gets FDA approval for prostate cancer drug Nubeqa

Bayer has secured approval from the US Food and Drug Administration (FDA) for its Nubeqa (darolutamide) to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

Pfizer gets FDA nod for biosimilar to Roche’s cancer drug Rituxan

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Ruxience (rituximab-pvvr), a biosimilar to Roche’s cancer drug Rituxan (rituximab), to treat certain cancers and autoimmune conditions.

FDA approves Baxter’s IV insulin Myxredlin

Baxter International has secured approval from the US Food and Drug Administration (FDA) for its Myxredlin (insulin human in 0.9% sodium chloride injection).