Abbvie has submitted applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to obtain approvals for upadacitinib (RINVOQ) to treat non-radiographic axial spondyloarthritis (nr-axSpA).
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to AbbVie’s telisotuzumab vedotin (Teliso-V) to treat nonsquamous non-small cell lung cancer (NSCLC).
The Ministry of Health, Labour and Welfare (MHLW) of Japan has approved Keytruda plus Lenvima combination to treat endometrial carcinoma.
Novartis has received the US Food and Drug Administration (FDA) approval for its Cosentyx (secukinumab) to treat children and adolescents with enthesitis-related arthritis and psoriatic arthritis
Novartis’ subsidiary Sandoz has submitted a marketing authorisation application to the European Medicines Agency (EMA) for the EirGenix-developed proposed trastuzumab biosimilar drug (150 mg).
ViiV Healthcare has received the US Food and Drug Administration (FDA) approval for Apretude (cabotegravir extended-release injectable suspension) as an injectable pre-exposure prophylaxis (PrEP) option for HIV prevention.
The European Commission (EC) has granted conditional marketing authorization (CMA) for Novavax’s Covid-19 vaccine Nuvaxovid.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for AstraZeneca’s Saphnelo (anifrolumab) in the European Union (EU) to treat adult patients with systemic lupus erythematosus (SLE).
The European Commission (EC) has approved Pfizer’s Cibinqo (abrocitinib) to treat moderate-to-severe atopic dermatitis (AD) adult patients.
The European Medicines Agency (EMA) has accepted to review Sanofi’s marketing authorization application (MAA) for olipudase alfa to treat acid sphingomyelinase deficiency (ASMD).
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