Approvals

AbbVie seeks approval for upadacitinib to treat nr-axSpA

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).

FDA grants breakthrough designation to AbbVie’s Teliso-V for NSCLC treatment

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).

Japan approves Keytruda plus Lenvima combination for endometrial cancer treatment

The Ministry of Health, Labour and Welfare (MHLW) of Japan has approved Keytruda plus Lenvima combination to treat endometrial carcinoma.

FDA approves Novartis’ Cosentyx to treat arthritis in children and adolescents

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

Sandoz seeks EMA approval for EirGenix’s trastuzumab biosimilar

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).

FDA approves ViiV Healthcare’s Apretude for HIV prevention

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.

Novavax gets EC marketing authorization for Covid-19 vaccine

The European Commission (EC) has granted conditional marketing authorization (CMA) for Novavax’s Covid-19 vaccine Nuvaxovid.

EMA’s CHMP recommends approval for AstraZeneca’s Saphnelo to treat SLE

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).

Pfizer’s Cibinqo receives EC approval for atopic dermatitis treatment

The European Commission (EC) has approved Pfizer’s Cibinqo (abrocitinib) to treat moderate-to-severe atopic dermatitis (AD) adult patients.