Regulation

AbbVie presents applications to FDA and EMA for approval of SKYRIZI in psoriatic arthritis

AbbVie has submitted applications seeking approval for SKYRIZI (risankizumab-rzaa, 150 mg) and SKYRIZI (risankizumab, 150 mg) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively, for the treatment of adults with active psoriatic arthritis.

USFDA extends review period for Eli Lilly and Incyte’s sNDA for baricitinib

The US Food and Drug Administration (FDA) has extended the review period for Eli Lilly and Incyte’s supplemental New Drug Application (sNDA) for OLUMIANT (baricitinib).

AbbVie announces extension of USFDA review period for Rinvoq sNDA

The US Food and Drug Administration (FDA) has extended the review period for AbbVie’s supplemental New Drug Application (sNDA) for Rinvoq (upadacitinib).

USFDA approves Abecma to treat relapsed or refractory multiple myeloma

The US Food and Drug Administration (USFDA) has approved Bristol Myers Squibb (BMS) and bluebird bio’s Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy.

Japan approves Bristol Myers Squibb’s B-cell lymphoma therapy

Bristol Myers Squibb has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for its Breyanzi (lisocabtagene maraleucel; liso-cel) to treat patients suffering from relapsed or refractory (R/R) large B-cell lymphoma (LBCL) and R/R follicular lymphoma.

EMA validates Gilead Sciences’ application for breast cancer therapy

The European Medicines Agency (EMA) has validated Gilead Sciences’ marketing authorization application (MAA) for sacituzumab govitecan-hziy (SG) to treat advanced breast cancer.

FDA approves Zealand Pharma’s Zegalogue for hypoglycemia treatment

Zealand Pharma has announced the US Food and Drug Administration (FDA) approval of its Zegalogue (dasiglucagon) injection for the treatment of patients aged six and above with severe hypoglycemia.

USFDA approves Janssen’s PONVORY for treatment of multiple sclerosis

Johnson & Johnson’s Janssen Pharmaceutical Companies have announced the US Food and Drug Administration (FDA) approval of PONVORY for the treatment of relapsing forms of multiple sclerosis (MS) in adults.

USFDA extends review period for AbbVie’s sNDA of upadacitinib

The US Food and Drug Administration (FDA) has extended the review period for AbbVie’s supplemental New Drug Application (sNDA) for upadacitinib.