News FDA clears first at-home device for depression Flow Neuroscience has secured FDA approval for FL-100, the first at-home brain stimulation device for major depressive disorder.
News FDA clears first gene therapy for rare genetic disease WAS Fondazione Telethon's Waskyra has become the first gene therapy in the US for Wiskott-Aldrich syndrome, and the first taken to market by a non-profit.
News BMS's Breyanzi is first CAR-T for marginal zone lymphoma Bristol Myers Squibb has taken CAR-T therapy into new territory, after getting FDA approval for Breyanzi in marginal zone lymphoma.
News Lilly gets approval for earlier use of Jaypirca in CLL Eli Lilly's fast-growing Jaypirca has won a new FDA approval as an earlier treatment for relapsed/refractory chronic lymphocytic leukaemia.
News J&J gets EU approval for Imaavy in gMG J&J's Imaavy has become the first FcRn blocker to be approved in the EU for both adolescent and adult patients with generalised myasthenia gravis.
News Innovent gets OK for China's first home-grown IL-23p19 drug Innovent has picked up approval in China for Pecondle, its anti-IL-23p19 antibody, as a treatment for moderate-to-severe plaque psoriasis.
News CHMP decision levels the playing field for GSK's RSV jab GSK's RSV vaccine is poised for EU approval in all adults aged 18 and over, bringing it into line with rival shots from Pfizer and Moderna.
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