Regulation - Approvals

FDA approves Applied Pharmaceutical’s IND application for APS03118

The US Food and Drug Administration (FDA) has approved investigational new drug (IND) application for Applied Pharmaceutical Science’s next generation RET original new drug, APS03118, to treat unlimited cancer types.

Galapagos’ Jyseleca gets UK marketing authorization for ulcerative colitis 

Galapagos has obtained marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Jyseleca (filgotinib 200mg tablets) to treat ulcerative colitis (UC) in Great Britain.

US FDA approves Pfizer’s Cibinqo for atopic dermatitis treatment

The US Food and Drug Administration (FDA) has approved Pfizer’s Cibinqo (abrocitinib) to treat moderate-to-severe atopic dermatitis (AD) in adult patients.

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.