Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.
Gilead Sciences has secured conditional marketing authorisation from the European Commission for its Veklury (remdesivir) to treat SARS-CoV-2 infection, which is responsible for the Covid-19 disease.
Specialist HIV company ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Rukobia (fostemsavir) 600mg extended-release tablets to treat HIV in adult patients.
Janssen Pharmaceutical, part of Johnson & Johnson, has secured marketing authorisation from the European Commission (EC) for its Ebola vaccine regimen to prevent Ebola virus disease.
Oncternal Therapeutics, a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, announced that the United States Food and Drug Administration (FDA) has granted the company orphan drug designations of cirmtuzumab for treatment of mantle cell lymphoma (MCL) and for treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL).
Pfizer has secured approval from the European Commission (EC) for its Daurismo (glasdegib) to treat certain adult patients with newly diagnosed acute myeloid leukaemia (AML).
GlaxoSmithKline (GSK) has secured approval in Japan for Duvroq (daprodustat) tablets for the treatment of anaemia caused by chronic kidney disease (CKD).
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
Roche has secured approval from the US Food and Drug Administration (FDA) for its Phesgo to treat early and metastatic HER2-positive breast cancer.
Bristol Myers Squibb and Acceleron Pharma announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of:
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