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.
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).
The US Food and Drug Administration (FDA) has extended the review period for AbbVie’s supplemental New Drug Application (sNDA) for Rinvoq (upadacitinib).
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.
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.
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.
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.
The US Food and Drug Administration (FDA) has extended the review period for AbbVie’s supplemental New Drug Application (sNDA) for upadacitinib.
Japan-based, R&D-driven Takeda Pharmaceutical Company Limited has submitted a New Drug Application (NDA) for lanadelumab to the Ministry of Health, Labour and Welfare (MHLW) in Japan.
Johnson & Johnson has secured authorisation for its Covid-19 vaccine under interim order (IO) from Health Canada for emergency use.
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