The US Food and Drug Administration (FDA) has declined to approve Eli Lilly and Company and Innovent Biologics’ investigational medicine sintilimab injection in combination with pemetrexed and platinum chemotherapy to treat nonsquamous non-small cell lung cancer (NSCLC).
The US Food and Drug Administration (FDA) has approved Merck’s anti-PD-1 therapy, Keytruda, to treat advanced endometrial carcinoma patients.
The US Food and Drug Administration (FDA) has extended the review period for Incyte’s supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura) to treat vitiligo.
AstraZeneca and Merck have obtained the US Food and Drug Administration approval for Lynparza (olaparib) to treat early-stage breast cancer.
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.
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