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 Appeals court turns Enhertu patent dispute on its head A US appeals court has reversed a 2023 decision that ordered Daiichi Sankyo to pay royalties on sales of cancer drug Enhertu to Seagen (now Pfizer).
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 Pazdur to leave FDA, shortly after taking CDER job Long-serving FDA figure Richard Pazdur has filed papers to retire, shortly after being appointed to lead CDER, according to reports.
News Ultragenyx to slash costs after Angelman trial failure Ultragenyx's therapy for the rare genetic disorder Angelman syndrome, apazunersen, has flunked a late-stage trial, crashing its share price.
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