The US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for BeOne Medicines’ B-cell lymphoma 2 (BCL2) inhibitor, sonrotoclax, and granted it priority review for use in treating adults with relapsed or refractory mantle cell lymphoma (R/R MCL).
UNICEF and Gavi, the Global Alliance for Vaccines and Immunisation now known as the Vaccine Alliance, have announced a pricing deal to expand access to the R21/Matrix-M malaria vaccine, aiming to protect almost seven million more children from the disease.
Otsuka Pharmaceutical has secured accelerated approval from the US Food and Drug Administration (FDA) for Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at disease progression risk.
Novartis has received approval from the US Food and Drug Administration (FDA) for the Itvisma (onasemnogene abeparvovec-brve) gene replacement therapy to treat spinal muscular atrophy (SMA).
AstraZeneca has announced a $2bn investment plan to expand its biomanufacturing presence in the US state of Maryland, aiming to support 2,600 jobs at its Frederick and Gaithersburg sites.
OSR Company Vaximm has signed a non-binding term sheet with Swiss-based life sciences investor BCM Europe (BCME) for a potential exclusive worldwide licence for Vaximm’s oral cancer immunotherapy platform, VXM01.
US-based Aspen Neuroscience has closed a Series C funding round, raising $115m to further the clinical development of its lead autologous cell therapy candidate, ANPD001, for moderate-to-advanced Parkinson’s disease.
Alvotech and Advanz Pharma have announced the European Commission’s (EC) marketing authorisations for Gobivaz, a biosimilar to Simponi (golimumab), across the European Economic Area (EEA).
Roche has received conditional marketing authorisation from the European Commission (EC) for Lunsumio (mosunetuzumab) subcutaneous (SC) for adults with relapsed or refractory follicular lymphoma (R/R FL) after at least two systemic therapies.
Insmed has received approval from the European Commission (EC) for Brinsupri (brensocatib 25 mg tablets) to treat non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and above with two or more exacerbations in the year preceding treatment.
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