The US Food and Drug Administration (FDA) has approved an expanded indication for Eli Lilly and Company’s Jaypirca (pirtobrutinib) as a first-line treatment for adults with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who do not have a 17p deletion.
The US Food and Drug Administration (FDA) has expanded the approved indication for Bristol Myers Squibb’s (BMS) Camzyos (mavacamten) to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults and paediatric patients weighing at least 30kg (66lb).
The US Food and Drug Administration (FDA) has approved Eli Lilly and Company’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults with type 2 diabetes (T2D).
The European Commission (EC) has granted marketing authorisation to NewAmsterdam Pharma and Menarini Group for Ubeslo (obicetrapib 10mg monotherapy) and Evlarco (10mg obicetrapib plus 10mg ezetimibe fixed-dose combination).
Japan’s Ministry of Health, Labour and Welfare has approved Viatris’ Wakix (pitolisant) for excessive daytime sleepiness (EDS) related to obstructive sleep apnoea syndrome (OSAS) and for narcolepsy types 1 and 2.
The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to RiboX Therapeutics’ investigational treatment RXRG001 for radiation-induced xerostomia (RIX) and hyposalivation.
The US Food and Drug Administration (FDA) is set to review Kowa Pharmaceuticals America’s new drug application (NDA) for K-911, an investigational once-daily eye drop aimed at reducing intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients.
ReviR Therapeutics has received a rare paediatric disease designation (RPDD) from the US Food and Drug Administration (FDA) for RTX-117, its investigational oral small-molecule therapy for Charcot-Marie-Tooth disease (CMT).
The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Tivicay PD (dolutegravir), for use with other antiretroviral agents in paediatric patients with human immunodeficiency virus type 1 (HIV-1) who weigh at least 2kg.
The European Commission (EC) has granted orphan designation to Lundbeck’s investigational monoclonal antibody asedebart (Lu AG13909) for the treatment of Cushing’s syndrome of endogenous origin.
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