The US Food and Drug Administration (FDA) has accepted Mirati Therapeutics’ new drug application (NDA) for its therapy adagrasib to treat KRASG12C-mutated non-small cell lung cancer (NSCLC) patients.
The US Food and Drug Administration (FDA) has approved Sanofi’s Enjaymo (sutimlimab-jome) to treat cold agglutinin disease (CAD) in adult patients.
Specialist HIV company ViiV Healthcare has secured the US Food and Drug Administration (FDA) approval for the expanded labelling of Cabenuva (cabotegravir, rilpivirine) to treat HIV-1 in adults.
Novavax has submitted a request seeking emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 vaccine candidate, NVX-CoV2373.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel) to treat several types of lymphoma.
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.
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 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.
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 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).
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