September 23, 2024
The US Food and Drug Administration has approved bimekizumab-bkzx (Bimzelx; UCB) for adult patients with active psoriatic arthritis (PsA), active nonradiographic axial spondyloarthritis (nr-axSpA) with objective […]
September 23, 2024
The Food and Drug Administration expanded the label of isatuximab-irfc (Sarclisa — Sanofi-Aventis) on September 20 to include treatment with bortezomib, lenalidomide, and dexamethasone for newly […]
September 23, 2024
The US Food and Drug Administration (FDA) has granted a second-line indication to amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) in non–small-cell lung cancer (NSCLC). Amivantamab with carboplatin […]
September 20, 2024
During its September 2024 meeting, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave the go-ahead for Penbraya (Pfizer) — meningococcal […]
September 20, 2024
The European Medicines Agency (EMA) has recommended granting marketing authorization for orphan medicine Hetronifly (serplulimab, Henlius Europe) to treat extensive stage small cell lung cancer (ES-SCLC). […]
September 20, 2024
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended the granting of marketing authorization for Hympavzi (marstacimab) for treating bleeding episodes […]
September 20, 2024
The European Medicines Agency (EMA) has announced its approval of two new biosimilar medications, Afqlir and Opuviz, to treat age-related macular degeneration (ARMD). The active ingredient […]
September 20, 2024
The European Medicines Agency (EMA) has determined that the medicinal product Elahere (mirvetuximab soravtansine, AbbVie Deutschland), indicated for the treatment of adults with folate receptor alpha […]
September 20, 2024
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the indication of the smallpox and mpox vaccine Imvanex to […]