Approvals

China’s NMPA clears Foresee’s Camcevi 42 mg for prostate cancer

China’s National Medical Products Administration (NMPA) has approved the marketing authorisation application (MAA) for Foresee Pharmaceuticals’ Camcevi 42 mg to treat adult patients with advanced prostate cancer.

FDA approves expanded indication for Lilly’s Jaypirca

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.

Bristol Myers Squibb secures expanded US approval for Camzyos

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).

FDA approves Lilly’s Onswik for type 2 diabetes in adults

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).

EC approves Menarini and NewAmsterdam’s obicetrapib therapies

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).

Viatris’ Wakix receives Japanese approval to treat OSAS and narcolepsy

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.

FDA grants RMAT designation to RiboX’s RXRG001 for xerostomia

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.

FDA grants RPDD to ReviR’s RTX-117 for CMT

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).

ViiV Healthcare’s Tivicay PD gains FDA approval for paediatric HIV therapy

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.