Regulation

AstraZeneca, Merck get FDA approval for Lynparza to treat breast cancer

AstraZeneca and Merck have obtained the US Food and Drug Administration approval for Lynparza (olaparib) to treat early-stage breast cancer.

Janssen submits application to EMA for mantle cell lymphoma therapy approval

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).

EMA accepts GlaxoSmithKline’s MAA for chronic kidney disease therapy

The European Medicines Agency (EMA) has accepted GlaxoSmithKline’s marketing authorisation application (MAA) for daprodustat to treat anaemia of chronic kidney disease (CKD).

FDA declines to grant approval for Gilead Sciences’ HIV treatment

The US Food and Drug Administration (FDA) has declined to grant approval for Gilead Sciences’ investigational therapy lenacapavir for HIV.

AbbVie files sNDA to FDA for chronic graft versus host disease therapy

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.

Japan approves Keytruda-Lenvima combo for renal cell carcinoma

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).

Dizal gets FDA fast track designation for Lymphoma therapy

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.

SwanBio gets FDA Fast Track designation for adrenomyeloneuropathy therapy

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.

FDA accepts new drug application of Mirati Therapeutics for NSCLC therapy

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.