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 NHS use of digital cardiac rehab tools endorsed Seven digital health technologies used to support people recovering from cardiovascular diseases have been recommended for use by the NHS.
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 FDA could hike user fees for ex-US drug programmes FDA mulls reduced fees for programmes with US-based phase 1 trials, and higher fees for those tested overseas, to incentivise US R&D.
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 AZ uses a priority review voucher for baxdrostat filing Seeking a lead over rival Mineralys, AstraZeneca is using a priority review voucher for its US filing for uncontrolled hypertension drug baxdrostat.
News MSD gets first FDA okay for oral PCSK9 cholesterol drug MSD has won the race to bring an oral PCSK9 inhibitor through to regulatory approval for LDL cholesterol-lowering in the US.
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