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.
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.
Takeda has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Orzeyful (oveporexton) to treat narcolepsy type 1 in adults.
Faeth Therapeutics has received the US Food and Drug Administration’s (FDA) fast track designation for the sapanisertib and serabelisib (PIKTOR) with paclitaxel combination to treat advanced or recurrent endometrial cancer.
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