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.
The European Medicines Agency (EMA) has validated Gilead Sciences’ marketing authorization application (MAA) for sacituzumab govitecan-hziy (SG) to treat advanced breast cancer.
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.
The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Pfizer and OPKO’s somatrogon, for review.
Specialist HIV company ViiV Healthcare has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to expand the use of Cabenuva.
Pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for priority review for TicoVac, a tick-borne encephalitis (TBE) vaccine.
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