The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application seeking approval for the new indication of Imbruvica (ibrutinib) plus bendamustine and rituximab (BR) combination from the European Medicines Agency (EMA).
The European Medicines Agency (EMA) has accepted GlaxoSmithKline’s marketing authorisation application (MAA) for daprodustat to treat anaemia of chronic kidney disease (CKD).
The US Food and Drug Administration (FDA) has declined to grant approval for Gilead Sciences’ investigational therapy lenacapavir for HIV.
AbbVie has submitted a supplemental new drug application (sNDA) for Imbruvica (ibrutinib) to the US Food and Drug Administration (FDA) to treat chronic graft versus host disease (cGVHD) in paediatric and adolescent patients.
The Ministry of Health, Labour and Welfare (MHLW) of Japan has approved Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination to treat radically unresectable or metastatic renal cell carcinoma (RCC).
The US Food and Drug Administration (FDA) has granted fast track designation for Dizal Pharmaceutical’s DZD4205 (Golidocitinib) to treat refractory or relapsed peripheral T-Cell Lymphoma (r/r PTCL) patients.
Gene therapy company SwanBio Therapeutics has secured Fast Track designation from the US Food and Drug Administration (FDA) for its AAV-based gene therapy, SBT101, to treat adrenomyeloneuropathy (AMN) patients.
The US Food and Drug Administration (FDA) has accepted Mirati Therapeutics’ new drug application (NDA) for its therapy adagrasib to treat KRASG12C-mutated non-small cell lung cancer (NSCLC) patients.
The US Food and Drug Administration (FDA) has approved Sanofi’s Enjaymo (sutimlimab-jome) to treat cold agglutinin disease (CAD) in adult patients.
Specialist HIV company ViiV Healthcare has secured the US Food and Drug Administration (FDA) approval for the expanded labelling of Cabenuva (cabotegravir, rilpivirine) to treat HIV-1 in adults.
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