News ASH: FDA okays Gamida aplastic anaemia therapy as data drops The first cell therapy for severe aplastic anaemia – Gamida Cell's Omisirge – has been approved by the FDA.
News CDC panel votes to scrap hepatitis B birth dose advice CDC advisers vote to overturn decades of US policy and abandon endorsement of universal hepatitis B vaccination for newborns in the US.
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 Setback for MSD as German court blocks Keytruda SC launch A court in Germany has granted an injunction that will prevent MSD from distributing the new, subcutaneous version of its cancer drug Keytruda.
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 Tracy Beth Hoeg will be fifth CDER head this year Tracy Beth Høeg, who has very little regulatory experience, is making the switch from CBER to replace FDA veteran Richard Pazdur.
News Lilly points to long-lasting weight loss with orforglipron Lilly breaks new ground for oral GLP-1 agonists with data showing it can help patients keep weight off after treatment with injectable therapies.
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