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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.
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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.
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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.
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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.
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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.
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