Swiss healthcare company Roche has received the US Food and Drug Administration (FDA) priority review for its Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in new-borns.
27 Jan 2022
24 Jan 2022
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.
19 Jan 2022
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.
17 Jan 2022
The US Food and Drug Administration (FDA) has approved Pfizer’s Cibinqo (abrocitinib) to treat moderate-to-severe atopic dermatitis (AD) in adult patients.
10 Jan 2022
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).
05 Jan 2022
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).
28 Dec 2021
The Ministry of Health, Labour and Welfare (MHLW) of Japan has approved Keytruda plus Lenvima combination to treat endometrial carcinoma.
24 Dec 2021
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
23 Dec 2021
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).
21 Dec 2021
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.