The US Food and Drug Administration (FDA) has approved two of Merck & Co’s (MSD) Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each combined with Padcev (enfortumab vedotin-ejfv), for adults with muscle-invasive bladder cancer (MIBC).
The US Food and Drug Administration (FDA) has declined to approve Unicycive Therapeutics’ resubmitted new drug application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
Eli Lilly and Company has entered into an agreement with Innovent Biologics for the commercialisation of Verzenios (abemaciclib) in mainland China.
Anixa Biosciences has secured a patent from the Korean Ministry of Intellectual Property (MOIP) for its breast cancer vaccine technology.
Sanofi has received approval from Japan’s Ministry of Health, Labour and Welfare for its subcutaneous (SC) formulation of Sarclisa (isatuximab) in combination with standard therapies to treat multiple myeloma (MM).
Alkermes has received orphan drug designations (ODD) from both the US Food and Drug Administration (FDA) and the European Commission (EC) for alixorexton, its investigational oral orexin 2 receptor (OX2R) agonist to treat idiopathic hypersomnia (IH) and narcolepsy.
ALK has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for EURneffy 1mg, a needle-free adrenaline treatment for children with anaphylaxis.
Roche has received the US Food and Drug Administration (FDA) priority review for its supplemental biologics licence application (sBLA) for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy for colon cancer.
Pfizer has received approval from the US Food and Drug Administration (FDA) for an expanded indication of Hympavzi (marstacimab-hncq) for the treatment of haemophilia A or B.
The European Commission (EC) has granted marketing authorisation for IntraBio’s Aqneursa (levacetylleucine) to treat neurological symptoms of Niemann-Pick disease type C (NPC).
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